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Sodium bicarbonate colon cleanse: Alkalising colonic irrigation with sodium bicarbonate. Instant online booking

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Alkalising colonic irrigation with sodium bicarbonate. Instant online booking

How expensive is a colonic Irrigation?

Although the cost is relevant, far more important is your health. A knowledgeable colonic irrigation therapist will listen to your questions and give you as comprehensive as possible answers. Besides, your practitioner can help you on the road to vital health.

Is there any aftercare advice?

Sure. Read more.

What is colonic irrigation?

Also known as a “Colonic”, “colon lavage”, colon hydrotherapy”, or “high Colonic”. Colonic irrigation is a safe, effective method for cleansing the colon of waste material by repeated, gentle flushing with water.

The colon, or large intestine, is the end portion of the human digestive tract (food carrying passageway extending from the mouth to the anus).

What is the purpose of having a colonic?

Firstly, this material is quite toxic (poisonous). Moreover, these poisons can re-enter and circulate in the bloodstream, making us feel ill, tired or weak. Secondly, impacted materials impair the colon’s ability to assimilate minerals and bacteria-produced vitamins. And finally, a build-up of content on the colon wall can inhibit muscular action causing sluggish bowel movements, constipation, and the result of these disorders.

What conditions treated?

   Many conditions benefit from colonic irrigation, including:

  • Allergies
  • Arthritis
  • Asthma
  • Atonic (sluggish) colon
  • Bloating
  • Candida
  • Colitis in remission
  • Constipation
  • Diarrhoea
  • Diverticulosis (i.e. Diverticulitis in remission)
  • Flatulence
  • Leaky gut
  • Haemorrhoids
  • Headache, toxic
  • Halitosis
  • IBS
  • Indigestion
  • Lethargy
  • Mucous colitis
  • Multiple sclerosis
  • ME
  • Parasitic infections
  • Skin problems: eczema, psoriasis, dermatitis, acne, etc.
  • Urinary urgency in females

How can I tell if I have toxic material in my colon?

This condition is prevalent in all civilised societies, and particularly in the UK. Common signs include headaches, backaches, constipation, fatigue, bad breath, body odour, irritability, confusion, skin problems, abdominal gas, bloating, diarrhoea, sciatic pain, and so forth. But the colon isn’t the only organ of elimination, what makes the colonic irrigation so important? While the lungs, skin, kidneys and liver also serve to eliminate toxins. Colonic irrigation is the most effective process available to accomplish this work quickly and easily.

What makes a colonic so unique?

In a 45 minute session, we use the filtered water for flushing the colon gently. Through appropriate use of massage, pressure points, etc., the colon therapist can work loose and eliminate far more toxic waste than any other short-term technique.

What will Colonics do to the colon?

   Specifically, colonic irrigation using to accomplish the following:

  1. Cleanse the Colon
  2. It Exercises the Colon Muscles
  3. Reshapes the Colon
  4. It Stimulates Reflex Points

It sounds like colonic irrigation may be useful for me, but will it be painful?

Usually, painful experiences are the result of resistance and tension. A professional colonic irrigation therapist is skilling at putting you at your ease and minimising discomfort. Most people enjoy the Colonic and are especially pleased with the unaccustomed sensation of feeling lighter, clean and clear afterwards.

Is it embarrassing to have a Colonic irrigation?

No, you will fully maintain your dignity. Besides, you will be in a private room with only your therapist, who fully appreciates the sensitivity of the Colonic irrigation procedure and will help you feel at ease. Your emotions will be acknowledged and honoured. After the gentle insertion of a small tube into the rectum, you are entirely covered. Rubber tubing carries clean water in and wastes out in a gravity pressured system.

Is there anything I need to do to get ready for colonic irrigation?

Since your abdomen will be massaged, it is a good idea to eat or drink lightly in the 2 hours immediately preceding a Colonic irrigation. Also helpful, but not essential, emptying the rectum with a bowel movement just before the Colonic irrigation saves time and permits more to be accomplished.

And what can I expect afterwards?

Most likely, you’ll feel great. Probably you’ll feel lighter and enjoy a sense of well-being. Not infrequently, someone having first colonic irrigation will remark that it was one of the most amazing experiences of their life. As soon as the colonic irrigation is finished, you can carry on with the daily routine. For some, the colonic irrigation may trigger several subsequent bowel movements for the next few hours, but there won’t be any uncontrollable urgency or discomfort. It’s also possible you may feel light-headed or chilled for a few moments following colonic irrigation.

Are colonics dangerous in any way?

Colonic irrigation, being a most natural, this process is virtually safe. We intend to provide a safe and healthy service so that you do not have to worry. As standard procedure, we clean and sterilise the necessary equipment.

Will colonic irrigation make me constipated or give me diarrhoea?

The most frequent post-colonic experience is to have a slight delay in bowel movements and then a resumption of a somewhat more significant, more comfortable to move stool. Sometimes if the colon is weak and sluggish, there may be no bowel movement for several days following colonic irrigation. However, this is not due to the colonic irrigation, but rather to the weakness of the colon. It could be due to the extra water introduced into the colon or to the stirring up of toxic waste. If this should occur, it is usually of short duration; however, since severe diarrhoea dehydrates the body.

Suppose I have been suffering from constipation for a long time, will colonic irrigation help?

We want to state that natural, harmless techniques, including the use of colonic irrigation, can successfully treat constipation. Constipation is one of what termed “civilised man’s diseases”. There are three factors involved in having a well-functioning colon: diet, exercise and attitude. All three must be in balance for the colon to function well. Often, however, because the colon has been sluggish for so long. The process of colonic irrigation is excellent for cleansing and healing the colon sufficiently so that changes in diet, exercise, and attitude are then able to produce their effects. Many people find the relief provided by colonic irrigation stimulates the motivation and enthusiasm to institute positive changes in their lifestyle.

Some people say that colonics wash out intestinal flora and valuable nutrients. Is this so?

Well, this is probably the most frequently asked question about colonic irrigation. So, the truth is that the washing out of putrefied material in the large intestine increases the population of probiotics. Moreover, good bacteria only breed in a clean environment. Therefore, the bowels of a newborn baby immediately begin to grow good intestinal flora. Each time you clean out the putrefying rubbish and make a better environment for the good flora, they start to multiply immediately in their natural media. By the way, probiotics produce vitamins “K” and “B” for us.

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How long does a colonic take?

Probably 90% of all Colonics take about 45 minutes. It could also be shorter or longer than that. That depends on the judgement of the therapist and sometimes, the wishes of the client. On first Colonic irrigation, you should expect to spend 90 minutes at the clinic.

Is there a special kind of water used for colonic irrigation?

We use highly filtered water. This kind of water is capable of absorbing and flushing more toxins out of the colon because of its drawing effect on solid particles, chemicals and other matter. It already has numerous chemicals and inorganic substances present.

Will it be all right to eat after having colonic irrigation?

We suggest that you eat at your regular mealtime, and consume a moderate amount of whatever seems gentle and nourishing to you. Then immediately drive it through mud, eating a meal known to cause trouble in your abdomen directly after a Colonic irrigation isn’t an intelligent choice. Besides, salads, vegetable soups or broths, fruit, or juices are the best choice.

Will one colonic empty the colon?

Rarely. Firstly, many of us have a considerable amount of impacted faeces in our colon. Secondly, there is a mental learning process involved in receiving colonics. As you become more aware of what is going on in your abdomen, and as your body learns how to allow the cleansing experience, you are better able to enter into that process. One colonic irrigation will remove some of the stagnant waste in the colon. The second and subsequent colonics will remove more. However, how many you may wish to have will depend upon your objectives.

How will I know when the colon is empty?

It will probably never be empty, as it’s an organ in continuous use. As more of the old impacted material leaves the bowel, you will feel the water enter higher sections of the colon without any sense of obstruction. The objective should not be an empty colon, but rather a well-functioning colon.

Will colonic irrigation clear up my skin?

Your skin actually “breathes” and is an essential organ of elimination of waste material. Sometimes, if the colon, liver or kidneys are functioning poorly, the skin will need to make up the difference. Cleansing and healing the colon diminishes the burden placed upon the skin as well as the other organs of elimination: lungs, liver and kidneys. As elimination is accomplishing through its proper channels, the skin will very often clear up.

We hope that the “Colonic irrigation questions and answers” has covered most of the possible uncertainties. If this is not the case, please contact us with any of the methods proposed on this site.

A contraindication is when we should NOT consider a colonic irrigation/enema.

ABDOMINAL HERNIAS are contraindications

The part of an internal organ that pushes through an opening in the organ’s wall.

ABDOMINAL SURGERIES are contraindications

After recent abdominal surgery since the administering of this procedure initiates peristalsis and the use of the abdominal muscles may aggravate sutures and the healing of the incision. Contraindications – A minimum of 12 weeks should pass after surgery, and must prescribed by physician.

ABNORMAL DISTENSION/MASSES

Distension – Bloating or swelling of the abdomen

ACUTE LIVER FAILURE

A disorder that is sudden and severe but lasts only a short time

ANEMIA

Not enough red blood, red blood cells, or haemoglobin in the body

ANEURYSM

A bulging out of part of the wall of a blood vessel

CARCINOMASare contraindications

Cancer of any type

CARDIAC CONDITION

If a client/user has had cardiac surgery or diagnosed with a heart condition such as uncontrolled hypertension of congestive heart failure, or other heart conditions.

CHROHN’S DISEASE

Causes inflammation in the small intestine) (The inflammation can cause pain and can make the intestines empty frequently, resulting in diarrhoea

COLITIS

Irritation of the colon and enema are contraindications.

DIALYSIS PATIENTS

Filtering of the blood to assist the kidneys

DIVERTICULITIS

(A condition that occurs when small pouches in the colon (diverticula) become infected or irritated) 
Diverticulosis – A condition that occurs when small pouches(diverticula) push outward through weak spots in the colon)(Medication can usually control disease)
(Diverticulum is a small pouch in the colon. These pouches are not painful or harmful unless they become infected or irritated.)

FISSURES/FISTULAS are contraindications

It is an abnormal passage between two organs or between an organ and the outside of the body. Damaged tissues may come into contact with each other and join together while healing. As a result, FISSURES/FISTULAS develope.

HEMORRHAGING

When a client/user has a flow of bright red from the rectum/anus

HEMORRHOIDECTOMY

It is a surgical procedure to remove haemorrhoids. That is to say, that you should obtain a Doctor’s Release a minimum of 12 weeks after removal of haemorrhoids.

INTESTINAL PERFORATIONS are contraindications

In short, a hole/rupture in the colon’s wall is contraindications

LUPUS(autoimmune diseases are contraindications)

(An autoimmune disease in which a person’s immune system attacks various organs or cells of the body) Lupus Patients have been noted to have colon perforations occur from the disease and the use of colonic irrigation/enemas can irritate the colon/bowel further.

PREGNANCY

Colonic irrigation/enemas contraindicated during the first and the last trimester of pregnancy. May be prescribed by OB/GYN Physician as an enema just prior to childbirth.

RECTAL SURGERY

Do not book colon hydrotherapy after recent rectal surgery. To clarify, you must not go for colonic sooner than a minimum of 12 weeks.

RENAL INSUFFICIENCIES are contraindications

Insufficient excretion of wastes by the kidneys

MEDICATION CONCERNS

If a physician has ever diagnosed your client/user with any intestinal conditions, or if your clients have been on any medications, which may weaken their intestinal walls, your client/user should obtain a doctor’s release. If your client’s/user’s are currently taking medication for any condition diagnosed by a physician, your client/user should check with their physician to ensure the drug will not interfere with the additional water intake and absorption.

Benefits of colonic irrigation are particularly noticeable in cases of such symptoms as: acne, psoriasis and other skin problems, asthma, allergies, persistent runny nose and colds, anxiety, depression and irritability, Arthritis, Bladder Infections, Bloated stomach and wind, Candida, Cellulite, Chronic fatigue syndrome, Constipation, Fluid retention, Food allergies, Halitosis (bad breath), Headaches and sinus problems, Haemorrhoids, Indigestion, Insomnia, Irritable bowel syndrome (IBS), Lethargy, Menstrual problems, pre-menstrual syndrome, Poor memory, Weakened immune system, Weight problems. 

Benefits of colonic as health improvements

Prices for colonic irrigation at the Parkland Natural Health in London

Clients have noticed different benefits of colonic as health improvements such as:

  • Lifting of spirits
  • Improved sleep
  • Balancing of mood swings
  • Improved weight control
  • The decrease in heartburn and indigestion
  • Improved skin condition
  • Regular and improved bowel movements
  • Improved sex drive
  • Improved digestion

A few more benefits of colonic irrigation

One of the most essential benefits of colonic irrigation is suppression of yeast infection so-called chronic candidiasis. Especially for this purpose, we offer a procedure using a low concentration sodium bicarbonate solution. All of the known strains of Candida simply do not survive in the bicarbonate of soda environment.

However, bicarbonate of soda is a very useful substance for human bodies and brings a few more benefits of colonic irrigation. Moreover, it is entirely natural for us because humans blood contains sodium bicarbonate. That is why we introduce this kind of treatment to kill Candida in the mucous membrane of the gastrointestinal tract. Sodium bicarbonate also retains potassium in the body.

These are just some of the benefits of colonic irrigation, which celebrities like Lisa Snowdon have enjoyed and endorse. Many people have undergone the process and will testify to its benefits, whether it is improved weight control, higher spirits or a better skin condition. If you are suffering from any of the symptoms above, then colonic irrigation should undoubtedly be a consideration.

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Health Benefits, Uses, Side Effects, Dosage & Interactions

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Baking soda for constipation: Does it work?

Constipation is a very common issue. In some cases, poor diet and exercise habits are the culprit. In others, medications or medical conditions may be the underlying cause.

Lifestyle changes, such as eating more fiber, drinking more water, and increasing exercise, are often the first line of treatment for constipation. If these lifestyle improvements fail, a doctor may recommend over-the-counter (OTC) or prescription laxatives to alleviate constipation.

Other people may wish to try home remedies, such as baking soda, to treat their constipation. There is little research to support this method, however.

Read on for more information on using baking soda for constipation and the potential risks.

There are two methods that some people may suggest to alleviate constipation using baking soda: soaking in a baking soda bath and drinking a solution of water and baking soda.

There is no scientific evidence to suggest that these methods can treat constipation.

Soaking in a baking soda bath

One potential method people have claimed will treat constipation is soaking in a bath that contains baking soda.

The idea is that the baking soda solution will relieve some of the discomfort people experience with constipation, as well as stimulate the anal sphincter. If this occurs, it may help an individual have a bowel movement.

To make a bath, a person can fill their tub with warm water and mix a few tablespoons of baking soda into the water. Once the baking soda dissolves, they can soak in the tub for as long as it is comfortable.

Drinking a baking soda solution

Baking soda is a common remedy for neutralizing stomach acid. Some people also claim that drinking baking soda may help promote bowel movements because it draws additional water into the digestive tract.

The theory is that this causes the digestive tract to contract, which can lead to a bowel movement.

To make a baking soda solution, add about a tablespoon of baking soda to a glass of water and mix it well. Once the baking soda dissolves, drink the solution.

However, in addition to not necessarily being an effective treatment, there may be risks for people who use baking soda for constipation.

Baking soda is typically safe for consumption. However, in rare cases, it can cause some side effects. Consuming too much baking soda may actually lead to constipation.

It may also cause:

  • vomiting
  • weakened muscles
  • convulsions
  • frequent urination
  • irritability
  • muscle spasms

In rare situations, baking soda could potentially lead to a ruptured stomach. Baking soda produces gas when it mixes with stomach acid. The stomach may rupture if it is full of this gas, and the gas cannot escape.

Baking soda may also affect whether a person’s medications are effective. For this reason, people should talk to a doctor before trying baking soda as a home remedy.

Finally, baking soda has a high sodium content. People on a reduced sodium diet should avoid consuming extra baking soda.

Often, fiber and increased water or liquid consumption can help alleviate constipation naturally.

Exercise can also help get a person’s bowels moving again. A person can try walking, running, swimming, or yoga to find constipation relief.

People may also want to try other home remedies, such as:

According to the U. S. Department of Health and Human Services, a person should see their doctor about constipation if:

  • they notice changes in bowel habits
  • they have serious stomach pains
  • they experience unintended weight loss
  • exercise, more fluid intake, stool softeners, and extra fiber do not help

Baking soda for constipation is not an evidence-based remedy for constipation and may or may not work.

Instead, a person should try to increase their fiber and water intake and exercise to see if they find relief for their constipation. OTC medications may also alleviate symptoms.

A person with frequent or persistent constipation should speak to a doctor about possible underlying causes.

Baking soda for constipation: Does it work?

Constipation is a very common issue. In some cases, poor diet and exercise habits are the culprit. In others, medications or medical conditions may be the underlying cause.

Lifestyle changes, such as eating more fiber, drinking more water, and increasing exercise, are often the first line of treatment for constipation. If these lifestyle improvements fail, a doctor may recommend over-the-counter (OTC) or prescription laxatives to alleviate constipation.

Other people may wish to try home remedies, such as baking soda, to treat their constipation. There is little research to support this method, however.

Read on for more information on using baking soda for constipation and the potential risks.

There are two methods that some people may suggest to alleviate constipation using baking soda: soaking in a baking soda bath and drinking a solution of water and baking soda.

There is no scientific evidence to suggest that these methods can treat constipation.

Soaking in a baking soda bath

One potential method people have claimed will treat constipation is soaking in a bath that contains baking soda.

The idea is that the baking soda solution will relieve some of the discomfort people experience with constipation, as well as stimulate the anal sphincter. If this occurs, it may help an individual have a bowel movement.

To make a bath, a person can fill their tub with warm water and mix a few tablespoons of baking soda into the water. Once the baking soda dissolves, they can soak in the tub for as long as it is comfortable.

Drinking a baking soda solution

Baking soda is a common remedy for neutralizing stomach acid. Some people also claim that drinking baking soda may help promote bowel movements because it draws additional water into the digestive tract.

The theory is that this causes the digestive tract to contract, which can lead to a bowel movement.

To make a baking soda solution, add about a tablespoon of baking soda to a glass of water and mix it well. Once the baking soda dissolves, drink the solution.

However, in addition to not necessarily being an effective treatment, there may be risks for people who use baking soda for constipation.

Baking soda is typically safe for consumption. However, in rare cases, it can cause some side effects. Consuming too much baking soda may actually lead to constipation.

It may also cause:

  • vomiting
  • weakened muscles
  • convulsions
  • frequent urination
  • irritability
  • muscle spasms

In rare situations, baking soda could potentially lead to a ruptured stomach. Baking soda produces gas when it mixes with stomach acid. The stomach may rupture if it is full of this gas, and the gas cannot escape.

Baking soda may also affect whether a person’s medications are effective. For this reason, people should talk to a doctor before trying baking soda as a home remedy.

Finally, baking soda has a high sodium content. People on a reduced sodium diet should avoid consuming extra baking soda.

Often, fiber and increased water or liquid consumption can help alleviate constipation naturally.

Exercise can also help get a person’s bowels moving again. A person can try walking, running, swimming, or yoga to find constipation relief.

People may also want to try other home remedies, such as:

According to the U. S. Department of Health and Human Services, a person should see their doctor about constipation if:

  • they notice changes in bowel habits
  • they have serious stomach pains
  • they experience unintended weight loss
  • exercise, more fluid intake, stool softeners, and extra fiber do not help

Baking soda for constipation is not an evidence-based remedy for constipation and may or may not work.

Instead, a person should try to increase their fiber and water intake and exercise to see if they find relief for their constipation. OTC medications may also alleviate symptoms.

A person with frequent or persistent constipation should speak to a doctor about possible underlying causes.

Baking soda for constipation: Does it work?

Constipation is a very common issue. In some cases, poor diet and exercise habits are the culprit. In others, medications or medical conditions may be the underlying cause.

Lifestyle changes, such as eating more fiber, drinking more water, and increasing exercise, are often the first line of treatment for constipation. If these lifestyle improvements fail, a doctor may recommend over-the-counter (OTC) or prescription laxatives to alleviate constipation.

Other people may wish to try home remedies, such as baking soda, to treat their constipation. There is little research to support this method, however.

Read on for more information on using baking soda for constipation and the potential risks.

There are two methods that some people may suggest to alleviate constipation using baking soda: soaking in a baking soda bath and drinking a solution of water and baking soda.

There is no scientific evidence to suggest that these methods can treat constipation.

Soaking in a baking soda bath

One potential method people have claimed will treat constipation is soaking in a bath that contains baking soda.

The idea is that the baking soda solution will relieve some of the discomfort people experience with constipation, as well as stimulate the anal sphincter. If this occurs, it may help an individual have a bowel movement.

To make a bath, a person can fill their tub with warm water and mix a few tablespoons of baking soda into the water. Once the baking soda dissolves, they can soak in the tub for as long as it is comfortable.

Drinking a baking soda solution

Baking soda is a common remedy for neutralizing stomach acid. Some people also claim that drinking baking soda may help promote bowel movements because it draws additional water into the digestive tract.

The theory is that this causes the digestive tract to contract, which can lead to a bowel movement.

To make a baking soda solution, add about a tablespoon of baking soda to a glass of water and mix it well. Once the baking soda dissolves, drink the solution.

However, in addition to not necessarily being an effective treatment, there may be risks for people who use baking soda for constipation.

Baking soda is typically safe for consumption. However, in rare cases, it can cause some side effects. Consuming too much baking soda may actually lead to constipation.

It may also cause:

  • vomiting
  • weakened muscles
  • convulsions
  • frequent urination
  • irritability
  • muscle spasms

In rare situations, baking soda could potentially lead to a ruptured stomach. Baking soda produces gas when it mixes with stomach acid. The stomach may rupture if it is full of this gas, and the gas cannot escape.

Baking soda may also affect whether a person’s medications are effective. For this reason, people should talk to a doctor before trying baking soda as a home remedy.

Finally, baking soda has a high sodium content. People on a reduced sodium diet should avoid consuming extra baking soda.

Often, fiber and increased water or liquid consumption can help alleviate constipation naturally.

Exercise can also help get a person’s bowels moving again. A person can try walking, running, swimming, or yoga to find constipation relief.

People may also want to try other home remedies, such as:

According to the U.S. Department of Health and Human Services, a person should see their doctor about constipation if:

  • they notice changes in bowel habits
  • they have serious stomach pains
  • they experience unintended weight loss
  • exercise, more fluid intake, stool softeners, and extra fiber do not help

Baking soda for constipation is not an evidence-based remedy for constipation and may or may not work.

Instead, a person should try to increase their fiber and water intake and exercise to see if they find relief for their constipation. OTC medications may also alleviate symptoms.

A person with frequent or persistent constipation should speak to a doctor about possible underlying causes.

Baking soda for constipation: Does it work?

Constipation is a very common issue. In some cases, poor diet and exercise habits are the culprit. In others, medications or medical conditions may be the underlying cause.

Lifestyle changes, such as eating more fiber, drinking more water, and increasing exercise, are often the first line of treatment for constipation. If these lifestyle improvements fail, a doctor may recommend over-the-counter (OTC) or prescription laxatives to alleviate constipation.

Other people may wish to try home remedies, such as baking soda, to treat their constipation. There is little research to support this method, however.

Read on for more information on using baking soda for constipation and the potential risks.

There are two methods that some people may suggest to alleviate constipation using baking soda: soaking in a baking soda bath and drinking a solution of water and baking soda.

There is no scientific evidence to suggest that these methods can treat constipation.

Soaking in a baking soda bath

One potential method people have claimed will treat constipation is soaking in a bath that contains baking soda.

The idea is that the baking soda solution will relieve some of the discomfort people experience with constipation, as well as stimulate the anal sphincter. If this occurs, it may help an individual have a bowel movement.

To make a bath, a person can fill their tub with warm water and mix a few tablespoons of baking soda into the water. Once the baking soda dissolves, they can soak in the tub for as long as it is comfortable.

Drinking a baking soda solution

Baking soda is a common remedy for neutralizing stomach acid. Some people also claim that drinking baking soda may help promote bowel movements because it draws additional water into the digestive tract.

The theory is that this causes the digestive tract to contract, which can lead to a bowel movement.

To make a baking soda solution, add about a tablespoon of baking soda to a glass of water and mix it well. Once the baking soda dissolves, drink the solution.

However, in addition to not necessarily being an effective treatment, there may be risks for people who use baking soda for constipation.

Baking soda is typically safe for consumption. However, in rare cases, it can cause some side effects. Consuming too much baking soda may actually lead to constipation.

It may also cause:

  • vomiting
  • weakened muscles
  • convulsions
  • frequent urination
  • irritability
  • muscle spasms

In rare situations, baking soda could potentially lead to a ruptured stomach. Baking soda produces gas when it mixes with stomach acid. The stomach may rupture if it is full of this gas, and the gas cannot escape.

Baking soda may also affect whether a person’s medications are effective. For this reason, people should talk to a doctor before trying baking soda as a home remedy.

Finally, baking soda has a high sodium content. People on a reduced sodium diet should avoid consuming extra baking soda.

Often, fiber and increased water or liquid consumption can help alleviate constipation naturally.

Exercise can also help get a person’s bowels moving again. A person can try walking, running, swimming, or yoga to find constipation relief.

People may also want to try other home remedies, such as:

According to the U.S. Department of Health and Human Services, a person should see their doctor about constipation if:

  • they notice changes in bowel habits
  • they have serious stomach pains
  • they experience unintended weight loss
  • exercise, more fluid intake, stool softeners, and extra fiber do not help

Baking soda for constipation is not an evidence-based remedy for constipation and may or may not work.

Instead, a person should try to increase their fiber and water intake and exercise to see if they find relief for their constipation. OTC medications may also alleviate symptoms.

A person with frequent or persistent constipation should speak to a doctor about possible underlying causes.

Baking soda for constipation: Does it work?

Constipation is a very common issue. In some cases, poor diet and exercise habits are the culprit. In others, medications or medical conditions may be the underlying cause.

Lifestyle changes, such as eating more fiber, drinking more water, and increasing exercise, are often the first line of treatment for constipation. If these lifestyle improvements fail, a doctor may recommend over-the-counter (OTC) or prescription laxatives to alleviate constipation.

Other people may wish to try home remedies, such as baking soda, to treat their constipation. There is little research to support this method, however.

Read on for more information on using baking soda for constipation and the potential risks.

There are two methods that some people may suggest to alleviate constipation using baking soda: soaking in a baking soda bath and drinking a solution of water and baking soda.

There is no scientific evidence to suggest that these methods can treat constipation.

Soaking in a baking soda bath

One potential method people have claimed will treat constipation is soaking in a bath that contains baking soda.

The idea is that the baking soda solution will relieve some of the discomfort people experience with constipation, as well as stimulate the anal sphincter. If this occurs, it may help an individual have a bowel movement.

To make a bath, a person can fill their tub with warm water and mix a few tablespoons of baking soda into the water. Once the baking soda dissolves, they can soak in the tub for as long as it is comfortable.

Drinking a baking soda solution

Baking soda is a common remedy for neutralizing stomach acid. Some people also claim that drinking baking soda may help promote bowel movements because it draws additional water into the digestive tract.

The theory is that this causes the digestive tract to contract, which can lead to a bowel movement.

To make a baking soda solution, add about a tablespoon of baking soda to a glass of water and mix it well. Once the baking soda dissolves, drink the solution.

However, in addition to not necessarily being an effective treatment, there may be risks for people who use baking soda for constipation.

Baking soda is typically safe for consumption. However, in rare cases, it can cause some side effects. Consuming too much baking soda may actually lead to constipation.

It may also cause:

  • vomiting
  • weakened muscles
  • convulsions
  • frequent urination
  • irritability
  • muscle spasms

In rare situations, baking soda could potentially lead to a ruptured stomach. Baking soda produces gas when it mixes with stomach acid. The stomach may rupture if it is full of this gas, and the gas cannot escape.

Baking soda may also affect whether a person’s medications are effective. For this reason, people should talk to a doctor before trying baking soda as a home remedy.

Finally, baking soda has a high sodium content. People on a reduced sodium diet should avoid consuming extra baking soda.

Often, fiber and increased water or liquid consumption can help alleviate constipation naturally.

Exercise can also help get a person’s bowels moving again. A person can try walking, running, swimming, or yoga to find constipation relief.

People may also want to try other home remedies, such as:

According to the U.S. Department of Health and Human Services, a person should see their doctor about constipation if:

  • they notice changes in bowel habits
  • they have serious stomach pains
  • they experience unintended weight loss
  • exercise, more fluid intake, stool softeners, and extra fiber do not help

Baking soda for constipation is not an evidence-based remedy for constipation and may or may not work.

Instead, a person should try to increase their fiber and water intake and exercise to see if they find relief for their constipation. OTC medications may also alleviate symptoms.

A person with frequent or persistent constipation should speak to a doctor about possible underlying causes.

Method, composition and kit for bowel cleansing

BACKGROUND OF THE INVENTION

Field of the Invention

[0001] The present invention relates to an improved method, composition, kit and kit for emptying and cleaning the colon prior to colonoscopy or in preparation for other medical, radiological and / or surgical procedures.

Introduction

[0002] Colon cancer mortality has declined steadily since the mid-1980s due to the widespread use of colonoscopy, both for the early diagnosis of the disease and for the removal of precancerous colon polyps detected by prophylactic colonoscopy.As a result, the American Cancer Society now recommends that all individuals over the age of 50 have a prophylactic colonoscopy every 10 years. An estimated 42 million more Americans have not received such a colon screening test to date. One of the reasons why people avoid this very important examination is the reluctance to undergo a complete bowel cleansing, which is mandatory before the examination. There are numerous stories of the salty and unpleasant taste of commercially available colon cleansing solutions that patients must drink prior to testing, and the taste of these products is one of the main reasons people avoid this potentially life-saving procedure.

[0003] In most medical or surgical procedures related to the colon, cleanliness requirements are an important prerequisite for various reasons: for example, in colonoscopy, cleanliness is a requirement for a complete and accurate examination, since stool residues or particulate matter substances can easily mask or hide polyps or flat cancers; and in colorectal surgery, cleanliness is very important to ensure the sterility of the operation. The ideal colon cleanser should be effective, complete and accurate imaging of the colon mucosa, safe for all patient populations, including diabetics or those with impaired renal function, acceptable to patients, and at a reasonable cost.A solution with a pleasant taste would be even more preferable.

Description of the current state of the art

[0004] In the past, numerous methods have been used to cleanse the intestines before medical or surgical procedures, including the use of various types of laxatives, bowel lavage solutions, suppositories and / or long-term diet therapy. In the past, large volumes of 0.9% saline solution, as well as poorly absorbed sugars such as mannitol or sorbitol, have been administered, but the significant absorption or loss of fluid and electrolytes from such drugs has sometimes led to serious complications in elderly frail patients. as well as in people with pulmonary heart problems.The modern era of colon cleansing was pioneered by Davis and Fordtran in 1980, with the development of osmotically balanced high volume solutions that did not show net absorption or excretion of fluids or electrolytes (Davis GL, Gastroenterology: 78: 991- 995, 1980).

[0005] Colon cleansing solutions can be compared in terms of their osmotic balance, or tonicity. Osmolality is a measure of the number of particles dissolved in a liquid and is measured in mOsm / kg.Osmolality can be measured directly using standard laboratory methods such as freezing point depression, or calculated by knowing which individual dissociated ions are present in solution. The osmotic activity of human serum or plasma changes in mOsm / liter and is called osmolarity. The normal osmolarity of human serum is approximately 285-295 mOsm / L. Tonality is the osmotic pressure created by solutions with different osmolality on both sides of the semipermeable membrane.On the basis of tonicity, colon cleansing solutions can be classified as isotonic, hypertonic, and hypotonic. Isotonic solutions have an equal number of non-penetrating molecules on both sides of the semipermeable membrane, and therefore are in equilibrium with the intestinal vascular system; there is no net absorption or loss of fluids or electrolytes by the body. Hypertonic solutions contain a higher concentration of non-penetrating substances than the surrounding fluid and can drain fluid into the intestinal tract.This process can lead to dehydration of the patient and an increase in serum electrolyte concentrations. Hypotonic solutions contain a lower concentration of non-penetrating substances than the surrounding fluid, which can lead to excessive absorption of free water from the intestine and undesirable dilution of serum electrolytes. Each such general category of colon cleansing solutions has advantages and disadvantages, but the sheer number of options described in the current state of the art indicates that an ideal formulation that is safe, effective and well tolerated for most patients is remains to be found.

[0006] Isotonic or balanced colon lavage solutions, originally described by Davis and Fordtran, contain a combination of electrolytes and a poorly absorbed water soluble substance, usually polyethylene glycol (PEG), which combination is in osmotic equilibrium with normal serum electrolyte concentrations in the vascular system of the intestinal tract. PEG is a complex non-absorbable inert ethylene oxide polymer that attracts and retains water introduced with the wash solution in the intestinal cavity due to the osmotic effect.The amount of PEG contained in such solutions is usually adjusted in accordance with the amount of electrolytes so that the osmolality of the final solution approaches the normal osmolality of human serum, i.e. about 285-295 mOsm / L. Typical PEG formulations include GoLYTELY®, a formulation originally proposed by Davis and Fordtran and commercially available from Braintree Laboratories of Braintree, NY. Massachusetts; and the more recent NuLYTELY® formulation based on Fordtran patent WO / 1987/000754, which lacks sodium sulfate and increases the amount of PEG in the final solution to keep the solution isotonic.Other known PEG formulations include a formulation available from Alaven Pharmaceutical, LLC (Marietta, Georgia) under the brand name TriLyte®, and a formulation available from Schwarz Pharma AG (Monheim, Germany) under the name Colyte®.

[0007] Colon cleansing is achieved by taking large volumes of these solutions, but since the solutions are isotonic, they do not cause any net gain or loss of water in the intestinal tract cavity. As a result, patients do not experience dehydration or major changes in water and electrolyte balance when using such solutions, and they are proven to be safe even when used by patients with pulmonary heart disease, kidney disease, or experiencing problems with an increase in fluid volume in the body.However, patients find it difficult to consume such isotonic solutions. The salty and bitter taste that results from the presence of electrolytes that are part of these solutions contribute to the nausea, vomiting and bloating that patients often experience when using these solutions, and even when these side effects are absent, patients often complain that using these solutions extremely unpleasant.

[0008] In one attempt to address these problems, Braintree Laboratories has marketed a product under the brand name HalfLYTELY®, based on US Pat. No. 7,921,324 to Dennett et al., according to which a few hours before the patient takes the washing solution, he is given bisacodyl tablets with prolonged action. Dennett et al. Argue that the volume of solution consumed can then be reduced from four liters to two liters, while still providing adequate cleansing.

[0009] Another isotonic formulation described in US Pat. No. 5274001 by Brody includes ascorbic acid or a salt thereof as an osmotically active substance, in addition to PEG and sodium sulfate.Brodiy et al. Report that ascorbic acid in such a composition acts as an additional osmotic agent, allowing to reduce the amount of liquid that needs to be consumed to three liters. This formulation has been marketed in Australia under the brand name GlycoPrepC ™ (manufactured by Pharmatel LLC, Sydney, Australia) for several years.

[0010] Hypertonic colon cleansing formulations contain high concentrations of osmotically active substances that, when consumed, attract and retain large amounts of water from the patient’s body into the intestinal tract, which then inflates the colon, stimulates peristalsis and evacuates the contents of the colon.Whereas in isotonic solutions the required amount of fluid, from two to four liters, is initially present as an integral part of the formula, hypertonic solutions draw out most of the necessary volume of fluid from the patient’s body. As a result, such formulations can cause sudden changes in fluid and electrolyte balance, dehydration, and an increase in serum electrolyte concentration, which can lead to irreversible renal dysfunction and even death in some patients if such drugs are taken without sufficient additional water intake.

[0011] The previously used hypertonic colon cleansing method involved the administration of solutions that contained hypertonic concentrations of poorly absorbed but potentially fermentable 6-carbon sugar alcohols such as mannitol or sorbitol. Reports of colon explosions and patient deaths from hydrogen and methane gases produced by the fermentation of these substances by bacterial flora during electrocautery during polypectomy (Bigard MA et al., Gastroenterology 77: 1307-1310, 1979) have led to a general consensus that simple or complex sugars should not be used in colon washout solutions.

[0012] The most widely used colon cleansers contain concentrated aqueous solutions of phosphate salts in liquid or tablet form (NaP) and thus minimize the problems and complaints associated with large volume PEG solutions. S.V. The Fleet Company (Lynchburg, VA) manufactured and marketed Fleet Phosphosoda® consisting of 480 g / L sodium phosphate monobasic and 180 g / L sodium phosphate dibasic. Randomized controlled trials of this formulation have shown that such solutions are equivalently efficacious and better tolerated than larger solutions containing PEG (Barkun A., Can. J. Gastroenterol. 20 (11): 699-710, 2006). However, this composition has an extremely salty and unpleasant taste. In addition, the high concentration of phosphate salts in these formulations causes a large influx of fluid and electrolytes into the intestinal cavity from the patient’s vascular system, leading to problems with dehydration, metabolic disorders, renal impairment, and even a number of deaths, which forced the FDA [FDA the quality of food and drugs in the United States – approx.translator] to issue a safety alert for Fleet Phospho-soda®. S.V. The Fleet Company then withdrew its product from the market. Salix Pharmaceuticals of Morrisville, NC continues to sell Osmoprep® sodium phosphate tablet formulation with a black box warning on the package [of the potential hazard of the drug – approx. translator]. InKine Pharmaceutical Company (now merged with Salix Pharmaceuticals) markets another NaP tablet formulation under the Visicol® brand.

[0013] US patent No. 6946149 (author Cleveland) describes a hypertonic solution of a smaller volume, which avoids the negative effects caused by the high content of sodium phosphate in known formulations by introducing sulfate salts (sodium, potassium and magnesium sulfates) into the mixture instead of phosphate salts. In a later patent application US 2009/0258090, the same author adds to such a mixture of sulfate salts and PEG also from 0.01 to 0.1 wt% of an artificial sweetener from the group of chlorinated sucrose isomers, including saccharin and / or sucralose.This reduces the perceived salinity of the solution to the equivalent of about 0.2-2.6% sodium chloride solution in water. Braintree Laboratories recently marketed this formulation under the brand name Suprep®, with FDA approval for this product only recently, in August 2010. Patients must drink 3 liters full volume if using the Suprep Colon Cleanse ® (1 liter of Suprep® in divided doses, with 1 liter of water to be drunk after every 500 ml of Suprep®).Cleaning and treatment results were similar when compared to Movieprep® or PEG-containing isotonic washes, but vomiting was slightly more common in the Suprep® group (DiPalma JA, Rodriguez R, McDown J, and Cleveland M., American Journal of Gastroenterology, 104: 2275-2284, 2010).

[0014] US Patent No. 7169381 to Barras describes a 2 liter hypertonic composition containing ascorbic acid or ascorbic acid salts, alkali metal sulfate and certain electrolytes in addition to PEG.Barras reports that this compound is equivalent in its effectiveness. earlier compositions of 3 or 4 liters, without the need for a prior dose of bisacodyl (Dulcolax®). This composition was marketed by Salix Pharmaceuticals under the brand name Movieprep®. However, the sodium sulfate and ascorbic acid components of Movieprep® still provide the solution with a salty, lime-flavored taste that many patients find unpleasant, so nausea and vomiting have also been reported with this drug (see below).link to DiPalma et al. above).

[0015] Another type of colon cleansing solution is described in Japanese Patent No. 2721929. This formulation includes the minimum fermentable sugar alcohols xylitol and / or erythritol with concentrations ranging from 5.0 to 35.0 grams per liter, as well as the appropriate amount of sodium and potassium electrolytes to maintain isotonicity. These sugar alcohols were specifically used in this composition to avoid the use of PEG in colon cleansing solutions. The lower concentrations of xylitol and / or erythritol, which are claimed in the patent, require a simultaneous increase in sodium sulfate and / or additional electrolytes to maintain isotonicity, which leads to an increase in the salinity of the taste and a deterioration in the palatability of the final solution.

[0016] As a result of these many unresolved problems in available methods, a growing number of clinicians are using a hypotonic mix of Braintree Laboratories’ Miralax® product containing PEG-3350 with two liters of Gatorade® or other sports drink / solution. for rehydration as a source of electrolytes (electrolyte rinsing solutions based on PEG, or PEG-ERP). This colon cleansing solution is believed to have the best taste (i.e.because it contains sugar and little salt), is inexpensive, and can be prepared by the patient himself entirely from products available on the open market. However, most sports drinks / electrolyte solutions contain up to 6% carbohydrates, including high fructose corn syrup, which is believed to lead to a number of health problems, especially in diabetics, and also carry risks of fermentation by bacterial flora in the colon to form potentially explosive gases hydrogen and methane.In addition, the relatively low concentration of electrolytes and the diluted state of these hypotonic compounds can lead to excessive absorption of free water, and further to fluid hypervolemia, blood thinning, and severe electrolyte imbalances, including low serum sodium levels (hyponatremia), which can cause brain swelling. confusion, seizures, and in rare cases, death of the patient. Despite these problems, the use of the non-FDA approved PEG-ERP formulation continues to grow.

[0017] Thus, there remains a need in the art for a colon cleansing composition with the following advantages:

improving the quality of bowel cleansing prior to colonoscopy, surgery, or radiological examination;

improved taste, allowing patients to take the entire volume of the drug in accordance with the appointment;

ease and convenience of patient preparation;

no risk of formation of potentially explosive gases as a result of bacterial fermentation of the solution;

no effect on insulin levels or blood sugar levels in diabetic patients; and

security.

Summary of the Invention

[0018] The present invention overcomes the drawbacks of previous solutions by providing a colon cleansing formulation that not only tastes better, but is also more balanced in electrolyte composition, safer for diabetics and other serious diseases, and is convenient for cooking. By incorporating sodium bicarbonate instead of sodium chloride, and combining an organic acid such as citric acid with sodium bicarbonate to form trisodium citrate as an alternative electrolyte replenishment agent, the present invention provides a better palatable electrolyte solution with a lower chlorine concentration. that, when combined with a suitable concentration of a suitable sugar alcohol such as xylitol (or, alternatively or as an additional component, erythritol, ribitol or arabitol) and polyethylene glycol, provides a colon cleansing solution with an improved taste and odor which, in certain embodiments embodiment of the invention, has a taste intensity approaching natural water.This high-tasting effervescent isotonic solution can be taken without additional sweetening, or higher concentrations of sugar alcohol can be used to produce a slightly hypertonic formulation with a pleasant Coca-Cola-like taste that acts even more effectively as a laxative by PEG and sugar alcohol both act as osmotic agents.

[0019] The invention includes an ingredient for use in preparing an electrolyte replenishing solution composition for an orally administered colon cleanser with significantly improved palatability.By limiting the chlorine content of the solution, while providing sufficient electrolytes to maintain proper electrolyte balance, the invention offers the advantage of encouraging the patient to take the indicated sufficient amount so as to provide adequate bowel cleansing for colonoscopy or other medical procedure. requiring bowel cleansing, without the disadvantages associated with drugs that are unable to maintain an adequate electrolyte balance in patients who take them.Accordingly, the proposed electrolyte replenishment solution is defined as a solution that contains a sufficient amount of selected serum electrolytes, such as sodium, potassium and chlorine ions, for example, to prevent unacceptable changes in fluid balance or serum electrolyte composition in patients taking such a solution.

[0020] Those of skill in the art will also agree that, in addition to electrolyte replenishment solution, an oral colon cleanser typically also includes polyethylene glycol as a suitable agent to provide the desired tonicity in the intestinal tract.In addition, as mentioned above, sugar alcohol can be used in combination with polyethylene glycol to enhance the laxative effect of the solution. In yet another embodiment of the invention, the sugar alcohol is present in a lower amount, which, while not appreciably affecting the laxative properties of the solution, nevertheless provides the additional benefit of removing the undesirable salty taste that is characteristic of other formulations used in the art.

[0021] In one example, therefore, the invention comprises an ingredient for significantly improving the palatability of an oral colon cleansing preparation and providing a patient with an electrolyte replacement solution, comprising: a low chlorine electrolyte component which, when dissolved in a pharmaceutically acceptable aqueous solvent for oral use, forms a base solution for electrolyte replenishment, containing not more than about 17 mEq of chlorine ions per liter of solution.Typically, the desired chlorine concentration is provided by the use of an appropriately limited amount of a pharmaceutically acceptable chloride salt. In addition, the solution may include one or more chlorine-free salts selected from the group consisting of potassium bicarbonate, sodium bicarbonate, and mixtures thereof, and an amount of citric acid that effectively forms trisodium citrate when such salts and citric the acid is dissolved in an aqueous solvent. In a preferred embodiment, the mixture will have a perceived salinity equivalent of 0.1 to 0.3% when the mixture is dissolved in one liter of solution, with the perceived salinity equivalent being defined as the equivalent salinity compared to the percentage of sodium chloride in the water.The equivalent perceived salinity of 0.3% is thus equal to the salinity of a 0.3% sodium chloride solution in water. The composition usually also contains a mixture of PEG with a molecular weight of 2000-8000 Daltons, and a sugar alcohol selected from the group consisting of xylitol, erythritol, ribitol, arabitol, and mixtures thereof. In a preferred embodiment, the combination of PEG and sugar alcohol will contain at least 90 wt% of the dry ingredients of the composition.

[0022] In yet another preferred embodiment of the invention, the subject of the invention is supplied dry as a kit of components.This option typically includes a source of electrolytes for a solution as described herein, a bicarbonate reagent such as citric acid, PEG as a high molecular weight agent to maintain the desired tonicity, and a sugar alcohol that can favorably affect palatability by decreasing the perceived salinity of the solution. and also, as an added advantage, increase the effectiveness of PEG as a colon flushing agent. In one particularly preferred embodiment, the dry component will be about 0.15 to 1.5 grams of potassium bicarbonate, 1.0-3.5 grams of sodium bicarbonate, 1.0-4.0 grams of citric acid, 0.1-1, 0 grams of sodium chloride, 50-140 grams of polyethylene glycol and 1-50 grams of sugar alcohol.Although xylitol is used in the examples, in other embodiments, the sugar alcohol may be selected from the group consisting of xylitol, erythritol, ribitol, arabitol, and mixtures thereof. These amounts are given per liter of solution prepared, and those skilled in the art will understand that these amounts can be adjusted in proportion to the specific volume of solution to be prepared to meet the ranges stated in the claims. In yet another preferred embodiment of the invention, the composition contains about 1 to 4 grams of sugar alcohol per liter.In an embodiment in which the sugar alcohol enhances the effect of PEG, the concentration or amount of the sugar alcohol may range from about 4 to 50 grams per liter. In general, it is preferred that the polyethylene glycol has an average molecular weight of 2000 to 8000 Daltons, more preferably 3000 to 4000 Daltons, and most preferably 3350 Daltons. In any event, it is also desirable that when the dry composition is dissolved in one liter of aqueous solution, such solution has an osmolality of about 275 to 500 mOsm per kilogram.Moreover, the ratio of polyethylene glycol to sugar alcohol can be adjusted to achieve the ideal balance. For example, in one preferred embodiment, the ratio of polyethylene glycol to sugar alcohol per unit volume of solution will be from about 2: 1 to about 60: 1, more preferably from about 1.20: 1 to 3.75: 1, or from about 25: 1 to about 75: 1.

[0023] The invention also includes the form of a solution. Thus, the invention also provides an ingredient for significantly improving the palatability of an oral colon cleansing preparation and providing a patient with an electrolyte replenishment solution comprising an aqueous solution of a pharmaceutically acceptable, low chlorine aqueous oral composition for colon cleansing containing not more than about 17 mEq of chlorine ions per liter of solution.In a preferred embodiment, the mixture will have a perceived salinity equivalent (as defined above) of 0.1 to 0.3%. The aqueous solution for electrolyte replenishment usually also includes one or more chlorine-free bicarbonate salts selected from the group consisting of potassium bicarbonate, sodium bicarbonate, and mixtures thereof, and citric acid. In such a solution, trisodium citrate is formed by the reaction of citric acid and a bicarbonate salt in this solution.Even more preferably, such a solution includes about 1.5-20 mEq Cl- ions (most preferably less than 20 mEq), about 10-60 mEq Na + ions, 1.5-15 mEq K + ions, 10-60 mEq HCO3- ions, and a sufficient amount of citric acid per liter of unit volume to form trisodium citrate. An even more preferred composition contains about 35-55 mEq Na + ions, 15-20 mEq Cl- ions, 5-10 mEq K + ions, and 10-20 mEq HCO3- ions per liter of solution. Although multiple ion donors can be used to obtain the desired ion concentration, bicarbonate and / or potassium chloride are preferred.Again, the preferred osmolality of the solution is about 275-500 mOsm / kg. Typically, the solution also includes about 50-140 grams per liter of polyethylene glycol with a molecular weight of about 2000-8000 Daltons and about 1-50 grams per liter of a sugar alcohol selected from the group consisting of xylitol, erythritol, ribitol, arabitol, and mixtures thereof. A particularly preferred solution contains about 1 gram per liter of NaCl, about 0.5-0.75 grams per liter of KHCO3, about 1.5-2.5 grams per liter of NaHCO 3 and about 1.5-2.5 grams per liter of citric acid.Such a solution usually also contains polyethylene glycol with a molecular weight in the range of about 3000-4000 Daltons and xylitol as the sugar alcohol. In one alternative formulation, such a solution contains about 110-120 grams per liter of polyethylene glycol with a molecular weight of about 3000-4000 Daltons and about 1-3 grams per liter of xylitol. Alternatively, the solution may contain about 60-75 grams per liter of polyethylene glycol with a molecular weight of about 3000-4000 Daltons and about 20-40 grams per liter of xylitol.

[0024] Each of the compositions of the present invention can be configured to be substantially sulfate ion free, practically free of phosphate ions, substantially free of magnesium ions, or substantially free of all such ions. Ideally, such compositions will not rely on the presence of such ions to achieve or enhance the laxative and cleansing effect of the composition, and therefore are considered substantially free of such ions for the purposes described herein, although small amounts of salts containing such ions may be present. as inert ingredients, such as a binder, in some formulation options.

[0025] The present invention also includes a method for preparing an aqueous solution for colon cleansing, comprising dissolving, per liter unit volume of aqueous solvent, about 0.15-1.5 grams of potassium bicarbonate, about 1.0 to 4 grams citric acid, about 1.0 to 3.5 grams of sodium bicarbonate, about 0.1 to 1.0 grams of sodium chloride, about 50.0-140.0 grams of polyethylene glycol with a molecular weight of about 2000-8000, and about 1.0 -50.0 grams of xylitol, erythritol, ribitol, arabitol and their mixtures.It will be understood by those skilled in the art that the aqueous solvent is based on water, although it may also contain additional ingredients such as flavors and the like. Accordingly, any of the known aqueous solvents suitable for use in mixing the oral solution can be used in addition to pure water.

[0026] In yet another embodiment of the invention, there is provided a convenient method for preparing an aqueous solution for colon cleansing, comprising mixing a dry composition containing about 1.0-4.0 grams of citric acid, about 0.15-1, 5 grams of potassium bicarbonate, about 1.0-3.5 grams of sodium bicarbonate, about 0.1-1.0 grams of sodium chloride, about 50-140.0 grams of polyethylene glycol with a molecular weight of about 2000-8000, and about 1.0 -50.0 grams of xylitol, erythritol, ribitol, arabitol and their mixtures per liter of unit volume of an aqueous solvent, and mixing these components in such an aqueous solvent until almost completely dissolved.

[0027] It is even more preferred that one or more of citric acid, potassium bicarbonate and / or sodium bicarbonate are added to such an aqueous solvent within a sufficiently short period of time before ingestion of the solution so that the received solution retains some degree of carbonation / effervescence immediately before taking.

[0028] A preferred methodology for cleansing the bowel of a patient, for example, in preparation for a colonoscopy or a medical, surgical, or radiological procedure, comprises administering the solution of the present invention to the patient.In another preferred embodiment of the invention, an effective amount of a laxative, such as bisacodyl or other suitable laxative, may be given about a day before the scheduled procedure to induce bowel movement. Then, about 4-6 hours after the first dose, and preferably after the bowel movement, the first liter of the composition according to the invention is taken. The next morning after taking said first liter, the second liter of the composition according to the invention is taken. In an even more preferred embodiment of the present invention, the solution is administered at about 250 milliliters every 15 minutes until one liter is consumed.Of course, experts understand that the reception does not have to be provided by a second person, and, as a rule, is not provided, but is carried out by the patient – the recipient of the composition – independently. It is preferred that the completion of the intake of the second liter of solution occurs at least 3 hours before the scheduled medical procedure. In another embodiment of the invention, the laxative is taken in the evening of the day preceding the day of the prescribed procedure, and the next morning, at least 6 hours before the procedure, 2 liters of the composition is taken in a 250 ml regimen every 15 minutes until the patient is enough of these two liters of volume has been drunk for almost complete cleansing of the patient’s colon.

[0029] The invention also includes a kit for the administration of a preparation of the present invention. For example, in an embodiment illustrating the present invention, the kit may include a first container sufficient to hold at least one liter of solution, a first mixture of polyethylene glycol, sodium chloride and selected sugar alcohol, and a second mixture of potassium bicarbonate, sodium bicarbonate, and citric acid. … In an even more preferred embodiment of the present invention, citric acid is in anhydrous form.In one alternative embodiment, the polyethylene glycol, sodium chloride and sugar alcohol are in sachet or bag form, and the mixture of potassium bicarbonate, sodium bicarbonate, and anhydrous citric acid is in tablet form. In another embodiment, the kit may include one or more sachets, wherein the potassium bicarbonate and sodium bicarbonate portion of the composition are not present in the same anhydrous citric acid sachet.In another preferred embodiment, all of the components of the invention are sealed in a single moisture-free sachet. These various embodiments of the invention serve to maximize the stability of anhydrous citric acid in the presence of bicarbonates.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

[0030] Preparation for routine prophylactic examinations such as colonoscopy must be not only safe but also tolerable to ensure collaboration from a healthy, symptom-free population.Unfortunately, despite the large selection of methods and formulations for colon cleansing, about 10-15% of colonoscopy attempts fail due to insufficient cleansing (Bels J., J Aliment. Pharm. Ther. 25: 373-384 , 2007), and significant problems remain related to their tolerance by patients, safety issues and side effects, as well as the relatively high cost of known compositions. The unpleasant and salty taste of existing colon cleansing solutions, often poorly obscured by artificial sweeteners or flavors, continues to be a significant obstacle for patients considering colonoscopy.Improving the taste of such solutions could lead to improved patient attitudes and greater success in preventive measures aimed at preventing the incidence of colon cancer in the population.

[0031] In an effort to address these prior art problems, the inventor found that the novel combination of the present invention creates a colon cleansing solution that is safer than the widespread Gatorade® / Miralax® preparation, and is better tolerated than other prescription solutions containing PEG , and tastes much better than any solution available.Specific unique blend of ingredients. described in the present invention, in its combination, gives a much less salty taste, as well as less intense mouthfeel, compared to the available solutions for colon cleansing.

[0032] The invention described herein is thus not only a palatable colon lavage solution, but, even more remarkably, can be formulated such that the resulting composition will have a perceived salinity equivalent to approximately 0.1% -0.3% sodium chloride in aqueous solution.A higher concentration of sugar alcohol in another embodiment of the invention can serve as an additional osmotic agent to provide an even more effective laxative with very few side effects such as nausea and vomiting in known solutions, and further enhances taste. The present invention, as described, for the first time includes sugar alcohol in a hypertonic solution in combination with PEG as a dual osmotic agent.

[0033] The invention also includes an easy method for mixing and applying the composition, and a kit for preparing for a colonoscopy or other medical, surgical or radiological procedure.

[0034] In a preferred embodiment, the composition comprises a combination of potassium bicarbonate and / or sodium bicarbonate, sodium chloride, PEG, citric acid, a suitable sugar alcohol selected from the group consisting of xylitol, erythritol, ribitol, arabitol and mixtures thereof, and an aqueous solvent.Preferably, these ingredients are combined so as to form a slightly hypotonic to slightly hypertonic solution in order to maintain the electrolyte balance of the serum of the patient to whom such a solution is applied.

[0035] The composition of the invention preferably contains salts of potassium bicarbonate and / or sodium bicarbonate, and more preferably a combination of both. When potassium bicarbonate is used, it may be present in an amount of about 0.15-1.50 grams per liter or more, or more preferably about 0.50-1.0 grams per liter, most preferably about 0.688 grams per liter.If sodium bicarbonate is used, it may be present in an amount of about 1.0-3.5 grams per liter, or more preferably in an amount of about 2.0-2.5 grams per liter, and even more preferably in an amount of about 2. 1 gram per liter.

[0036] In another preferred embodiment of the invention, the composition according to the invention preferably contains citric acid, and preferably in anhydrous form. When used, anhydrous citric acid is present in an amount of about 1.0-4.0 grams per liter, more preferably about 1; 5-3.0 grams per liter.Anhydrous citric acid is most preferably present in an amount of about 2.0 grams per liter. When added to the formulation with sodium in an aqueous medium, the reaction between anhydrous citric acid and sodium bicarbonate in solution results in trisodium citrate and CO2 effervescent gas. This effervescence from gas bubbles has been found to improve the palatability of the composition, and this encourages patients to consume the entire prescribed volume to achieve high quality colon cleansing.In addition, trisodium citrate formed when the composition of the present invention in dry powder form is mixed with water creates an additional bicarbonate substitute to help maintain proper electrolyte balance and rehydration without imparting additional sodium flavor to the composition. This is a significant improvement as other existing rinses with higher sodium concentrations in the form of sodium chloride, sodium sulfate and sodium bicarbonate have significant taste and patient compliance issues.Trisodium citrate is used as a substitute for bicarbonate in oral rehydration solutions (ORS) recommended by the World Health Organization and is used in the treatment of patients with severe diarrhea and acidosis (Islam, MR., Bulletin of the World Health Organization, 64 (1): 145- 150, 1986). A drop in serum bicarbonate concentration has been noted after the use of some known wash solutions such as 0.9% sodium chloride or mannitol and, to a lesser extent, Movieprep®.This loss of bicarbonate in rectal exudate can have serious clinical consequences, including a decreased ability to maintain a proper blood pH (acidosis), and lead to nausea, vomiting, weakness, disorientation, and dehydration.

[0037] The composition of the invention may also contain sodium chloride as a source of sodium and chlorine ions. When used for this purpose, sodium chloride is preferably present in an amount of about 0.10-1.0 grams per liter, and most preferably in an amount of about 1.0 grams per liter.

[0038] The composition of the invention also contains a high molecular weight polymer, such as, for example, commercially available polyethylene glycol (PEG). When PEG is used as a high molecular weight polymer, it most preferably has an average molecular weight of 3350 Daltons (PEG-3350). While PEG-3350 is used in the examples of the preferred embodiment of the invention, it is also possible to use PEG with a molecular weight in the range of about 2000 to about 8000 Daltons, especially 3000-4000 Daltons.PEG is preferably present in an amount of about 50.0-140.0 grams, more preferably 68.0-120.0 grams per liter of liquid.

[0039] The composition according to the invention also preferably contains a sugar alcohol. The sugar alcohol is preferably present in an amount of about 1.0-50.0 grams per liter, and more preferably 2.0-30.0 grams per liter. Xylitol and erythritol are natural plant-derived sugar substitutes that do not raise blood sugar or insulin levels, are considered safe for diabetics and are preferred.Doses of xylitol up to 50 grams per day taken for more than two years, according to Makinen, did not have a toxic effect on the human body (Makinen KK. Long term tolerance of healthy human subjects to high amounts of xylite and fructose. Int. Z Vitam Emahrungsforsch Beih 15: 9-14 1976). In another study, consumption of erythritol in doses up to 50 mg did not result in any painful symptoms in the gastrointestinal tract, but doses of xylitol in excess of 35 grams resulted in much more watery stools than the same doses of erythritol.(Storey D, et al., “Gastrointestinal tolerance oferitrite and xylite ingested in a liquid,” European Journal of Clinical Nutrition, 2006: 1-6). Suitable sugar alcohols should not be appreciably fermented by bacteria in the intestine so as not to pose the risk of the formation of explosive gases noted in some earlier formulations. Ribitol and / or arabitol also have suitable properties for use in the composition.

[0040] By using a minimum fermentable four- or five-carbon sugar alcohol instead of a fermentable sugar, a 5-carbon sugar (such as xylose), or a 6-carbon sugar alcohol (such as mannitol or sorbitol), and an effective amount of PEG as a second active osmotic agent, the invention of the present disclosure takes advantage of the combined action of two or more osmotic agents used together in a colon cleansing formulation.Accordingly, the present invention provides a significant improvement by using sugar alcohol (instead of simple or complex sugars) in combination with PEG over colon cleansing formulations currently used before colonoscopy or in preparation for medical, radiological and / or surgical procedures. … A comparison of a particularly preferred embodiment of the invention, namely the novel composition described, with other representative chlorine-containing PEG wash solutions is shown in Table I.

Table I
Comparison of the present invention and representative chlorine-containing prior art
PEG-based solutions
Ingredients PEG NaCl KCl KHCO3 NaHCO3 Na2SO4 Citrate Ascorbate Flavor / Carbohydrate
Invention 120 1.00 0 0.688 2.10 0.0 2.0 0.0 2 g xylitol
GoLytely 64 1.46 0.745 0.0 1.68 5.685 0 0.0 no
NuLytely 120 5.60 0.74 0.0 1.43 0.0 0 0.0 Flavor combination in
Movieprep 100 2.69 1.015 0.0 0.0 7.5 0 6.1 aspartame
PEG / ERP 120 0.44 0.12 0.0 0.0 0.0 0 0.0 High fructose corn syrup

[0041] In the most preferred embodiment described above, a dry composition consisting of about 0.688 grams of potassium bicarbonate, about 2.1 grams of sodium bicarbonate, about 2.0 grams of citric acid, about 1-0 grams of sodium chloride, about 120 grams of PEG 3350, and about 2.0 grams of xylitol, are mixed in one liter of water or other aqueous medium.The skilled person will understand that a composition according to a preferred embodiment of the invention can be prepared by mixing two Alka-Seltzer Gold tablets, one 1 gram sodium chloride tablet, one 2 gram sachet of xylitol, and 120 grams of PEG sold under the Miralax® brand in one liter of water.

[0042] Although Alka Seltzer Gold® (manufactured by Bayer Aktiengesellschaft, Leverkusen, Germany) has been developed long ago and has been marketed as an over-the-counter remedy for heartburn, acid indigestion or dyspepsia for many years, formula can also be used, in proper proportions, for a more balanced and physiological replacement of electrolytes in the colon cleansing solution as described herein.Each Alka Seltzer Gold tablet contains 1.0 grams of citric acid anhydrous, 0.344 grams of potassium bicarbonate, and 1.05 grams of sodium bicarbonate, and the usual recommended dose for heartburn and indigestion is two (2) tablets dissolved in 4 ounces of water. The bicarbonate present in Alka Seltzer Gold reacts to neutralize the hydrochloric acid present in the stomach to form sodium chloride, water and carbon dioxide gas (CO2), which is believed to stimulate belching and relieve intragastric pressure, and to some extent reduce acidity of the stomach.The reaction of citric acid and bicarbonate in tablet form when dissolved in a glass of water is described by the following equation:

[0043] It has been found that the formation of gas bubbles due to the formation of CO2 gas improves the palatability of the product. It is important to note that the only product of the Alka Seltzer family that is used in this particular preferred embodiment is Alka Seltzer Gold, since all other forms of Alka Seltzer contain aspirin in amounts that can adversely affect the intestinal mucosa.

[0044] The composition of the invention as described above can be prepared in the form of a dry powder for dissolution in water or other aqueous medium. Single doses of dry powder can be supplied in sealed individual bags or sachets, or one or more tablets to be dissolved in 1 liter of water or other aqueous medium in a large mug or other container of the patient’s choice.

[0045] In addition to the above ingredients, the composition of the invention may further contain other ingredients such as coloring agents or fragrances.Suitable flavoring ingredients can be natural or artificial compounds, or combinations thereof, and used to impart a pleasant taste and / or odor to the preparation. Examples include cola nut extract, cherry flavor extract, caramel flavor extract, anise oil, cinnamon oil, vanilla, vanillin, cocoa, chocolate, menthol, grape, peppermint oil, wintergreen oil, garlic oil, bay oil, anise oil, eucalyptus, thyme oil, juniper oil, nutmeg oil, sage oil, bitter almond oil, acacia oil; citrus oils such as lemon, orange, lime and grapefruit; and fruit essences including apple, pear, peach, berries, coffee beans, wild berries, dates, blueberries, kiwi, strawberries, raspberries, cherries, plums, pineapple and apricot, as well as commercially available flavor kits.Suitable coloring agents include compounds used to impart color to solid or liquid preparations; including, for example, FD&C Red No.3, FD&C Red No.20, FD&C Yellow No.6, FD&C Blue No.2, D&C Green No.5, FD&C Orange No.5, D&C Red No.8, burnt sugar and iron oxides. Coloring agents can also be pigments, dyes and tones, titanium dioxide, natural coloring agents such as grape peel extract, dried red beet, beta-carotene, annatto, carmine, turmeric and paprika.

[0046] The present invention may be a kit containing two unit doses of the composition, either in granular dry powder form or in tablet form, together with a suitable container or containers for preparation and administration. A single dose of the composition can be packaged in separate sachets in two or more component forms, or in one hermetically sealed and moisture-free sachet to maintain the stability of the composition. The combination of citric acid and bicarbonates in the formulation in the presence of moisture leads to the formation of gas bubbles.It is therefore preferable to pack the composition in sealed and dry bags or container, or separate these components into separate sachets before dissolving in the final solution. In one example, potassium bicarbonate, sodium bicarbonate, and citric acid are in tablet form in a sealed dry bag, while sodium chloride, PEG and sugar alcohol are in another bag. In the second example, citric acid and bicarbonates are each packed in an individual sachet, and the rest of the ingredients are divided between the two sachets.In the third example, all the solid components of the formulation are packaged in one hermetically sealed and dry sachet, which is placed in any type of hermetically sealed container. The sachets can be vacuum packed to evacuate air. The formulation packaged in this way and tested for electrolytic stability after 30 days showed no change in electrolyte balance.

[0047] The compositions included in the kit can be supplied in containers of any kind, ensuring the safety of the various components and the absence of interaction with the container material, leading to a change or absorption of the ingredients.For example, suitable containers include bottles made of glass, organic polymers such as polycarbonates, polystyrene, and the like, or any other material commonly used for storing reagents or food; envelopes, which may be lined with aluminum or aluminum alloy foil. The containers can have two compartments. separated by an easily removable membrane, and after it is removed, the components are mixed. Removable membranes can be glass, plastic, rubber, etc.n. Kits may be accompanied by instructions and manuals. The instructions can be printed on paper or other material, and / or can be supplied on electronic media. Detailed instructions can be physically separated from the kit; instead, the user may receive instructions on how to find the website specified by the manufacturer or distributor of the kit, or receive instructions by email.

[0048] The present invention also provides a method for cleaning the colon before colonoscopy or in preparation for other medical, radiological and / or surgical procedures, comprising oral administration of a preparation containing, per liter of liquid, the following components:

90 290 0, 15-1.5 grams of potassium bicarbonate;

1.0-3.5 grams of sodium bicarbonate;

1.0-4.0 grams of citric acid;

0.1-1.0 grams of sodium chloride;

50.0-140.0 grams of commercially available PEG; and

1.0-50.0 grams of a minimum fermentable sugar alcohol selected from the group consisting of xylitol, erythritol, ribitol, arabitol, and mixtures thereof.

[0049] In another preferred embodiment of the invention, the patient may take a dose of the laxative 4-6 hours prior to ingestion of the rinsing solution. The laxative causes rhythmic contractions of the muscles of the large intestines. This category of laxatives includes, but is not limited to this list: bisacodyl, senna, hay, or buckthorn. Of course, larger or smaller doses can be used as needed to allow a bowel movement within 6 hours while avoiding unnecessary discomfort.

[0050] In one preferred embodiment of the invention, the patient first takes 10 to 40 mg of tableted bisacodyl as a laxative at least 4-6 hours before starting the liquid wash solution on the evening of the day prior to the scheduled examination. After about 6 hours, or preferably after having a bowel movement in response to bisacodyl, the patient makes 1 (one) liter of solution by pouring the sachet or sachets containing a single dose of the dry composition into a suitable container, large mug or bottle, and then adding one liter water or other aqueous solvent.After stirring for several minutes and the appearance of gas bubbles, the patient swallows the resulting aqueous solution in the mode of about 250 ml (8 ounces) every 10-15 minutes until he has drunk the entire volume in an amount of one liter, preferably within one hour. On the day of the planned procedure and at least four hours before the start of the examination, the patient repeats the same steps: prepares and mixes the contents of the package (s) of the second single dose of the dry composition in 1 (one) liter of water or other aqueous medium, and takes the whole the volume of the resulting aqueous solution in the mode of about 250 ml (8 ounces) every 10-15 minutes, until you have drunk the entire volume.

[0051] In another preferred method, particularly useful in preparation for a procedure scheduled later in the day, the patient only takes 10 to 40 mg of bisacodyl (Dulcolax®) the night before. In the morning of the examination day and no less than about six hours before the start of the scheduled procedure, the patient dissolves both single doses of the dry mixture of the composition in 2 (two) liters of water or another aqueous solvent. As in the previous method, the solution is stirred until gas bubbles appear, and then drunk in the mode of about 250 ml (8 ounces) every 10-15 minutes, until the entire volume in the amount of 2 (two) liters is drunk.

Examples

[0052] The following examples are included herein to demonstrate preferred embodiments of the invention. Those of skill in the art should understand that the compositions and methods disclosed in the examples represent those that the inventor has found to function well in the practice of the invention, and therefore may be considered preferred. However, those skilled in the art should also understand, in light of the present disclosure, that numerous changes can be made to any particular embodiment of the invention, which nevertheless will produce identical or similar results without departing from the spirit and scope of the invention.

Example 1

[0053] A preferred composition according to the invention was selected and mixed with one liter of distilled water. Such a preferred composition of the invention contained 0.688 grams of potassium bicarbonate, 2.1 grams of sodium bicarbonate, 2.0 grams of citric acid, 1.0 grams of sodium chloride, 120.0 grams of PEG and 2.0 grams of xylitol. The weight ratio of PEG to xylitol in this preferred embodiment was 60: 1 and the calculated osmolality was 277 mOsm / kg. The concentration of electrolytes in solution was determined with an automatic analyzer Beckman D × C 600i Synchronous Access Clinical System.The resulting solution had a sodium concentration of 43 mmol / L, a chlorine concentration of 17 mmol / L, a potassium concentration of 7 mmol / L, and a bicarbonate concentration of 16 mmol / L.

Example 2

[0054] In a pilot study, two healthy volunteers drank two liters of the preferred isotonic solution described in Example 1 in a divided dose. Both volunteers achieved adequate cleansing without significant stomach cramps, nausea and vomiting. Before and after taking the drug, blood was taken from the subjects of study for analysis.The results are shown in Tables I and II. A paired-sample study confirmed that there were no statistically significant changes in electrolyte composition, renal function, or serum calcium, with a statistical significance level of 0.05.

Table I
Object 1 (56 years old, male), isotonic preparation
Before preparation After preparation
Glia 97 84
Na 138 140
K 4.6 4.1
C1 102 100
CO2 29 29
AMK 13 12
Cr 0.8 0.8
Ca 9.3 9.2
Albumin 4.3 4.1
Table II
Object 1 (52 years old, female), isotonic preparation
Before preparation After preparation
Glia 91 96
Na 140 138
K 4.4 4.1
Cl 104 103
CO2 29 29
AMK 12 5
Cr 0.8 0.8
Ca 9.1 9.2
Albumin 3.7 4.0

Example 3

[0055] In a pilot study, a healthy volunteer drank a preferred formulation of the invention in a dosing regimen as described in the hypertensive embodiment of the formulation of the invention.This embodiment of the composition according to the invention contained 0.688 grams of potassium bicarbonate, 2.1 grams of sodium bicarbonate, 2.0 grams of citric acid, 1.0 grams of sodium chloride, 68.0 grams of PEG and 30.0 grams of xylitol, dissolved in 1 liter of water. The weight ratio of PEG to xylitol in this preferred embodiment was 2.3: 1 and the calculated osmolality was 355 mOsm / kg. With this composition, an even more effective cleansing was achieved, without significant spasms, nausea and vomiting as a result of taking the solution.Before and after taking the drug, blood was taken from the subjects for analysis for electrolyte content, renal function, and serum calcium. There were no significant changes in these indicators, as shown in Table III.

Table III
Object 1 (56 years old, male), hypertensive drug
Before preparation After preparation
Glia 92 85
Na 139 143
K 4.6 4.8
C1 13 12
C02 29 32
AMK 13 12
Cr 0.8 0.9
Ca 9.6 9.6
Albumin 2.2 2.6

Example 4

[0056] Ten healthy volunteers were each given 10 cc samples.ml of an electrolyte replenishment solution (containing 0.688 grams of potassium bicarbonate, 2.1 grams of sodium bicarbonate, 2.0 grams of citric acid and 1.0 grams of sodium chloride dissolved in 1 liter of distilled water), as well as a preferred embodiment of the composition according to the invention (containing 0.688 grams of potassium bicarbonate, 2.1 grams of sodium bicarbonate, 2.0 grams of citric acid, 1.0 grams of sodium chloride, 120.0 grams of PEG and 2.0 grams of xylitol dissolved in 1 liter of distilled water) and asked to indicate to which of the four reference solutions of salt (sodium chloride in water) – with a concentration of 0.1%, 0.2%, 0.3%, or 0.4% by weight – is the perceived salinity of each solution closer.Sixty percent (60%) of those who tried the electrolyte replenishment solution chose the 0.2% solution as the closest in terms of perceived salinity. Regarding the preferred composition, 50% chose a 0.3% solution, and 40% -0.2% solution as the closest in perceived salinity. None of the objects of study chose a 0.4% solution as the closest solution in terms of perceived salinity for any of the two samples under study. The results of the experiment are summarized in Table IV.

Table IV
Perceived salinity of solutions (10 volunteers)
Compared solutions Number of users who chose 0.1% NaCl Number of those who chose 0.2% NaCl Number of those who chose 0.3% NaCl Number of those who chose 0.4% NaCl
Solution for electrolyte replenishment 2 6 2 0
Preferred composition 1 4 5 0

Example 5:

Seventy volunteers were asked to taste, in a blind study, 2 ml samples of each of three solutions presented in random order, including the formulation of the present invention, Golytely®, and MoviePrep®.The preferred composition of the invention used in this part of the study contained 0.688 grams of potassium bicarbonate, 2.1 grams of sodium bicarbonate, 2.0 grams of citric acid, 1.0 grams of sodium chloride, 120.0 grams of PEG and 2.0 grams of xylitol. dissolved in 1 liter of water. Each “masked” sample was ranked in 4 groups as 1) most salty, 2) least salty, 3) best tasting (most likely 64 ounces), and 4) most delicious. To compare the results, a chi-square test was performed.The composition of the present invention was the preferred solution with a p-value <0.001. The results are summarized in Table V.

Table V
Blind taste examination (70 objects)
Solution A (Invention) Solution B (Golytely) Solution C (MoviePrep) p-value
most salty 0 46 (66%) 23 (34%) <0.001
least salty 65 (93%) 2 (3%) 3 (4%) <0.001
with the best taste 49 (70%) 6 (9%) 15 (21%) <0.001
the most delicious 38 (54%) 6 (10%) 26 (37%) <0.001

Example 6

[0057] Forty-three healthy adults undergoing routine outpatient colonoscopy and who previously had history of intolerance to other commercially available colon cleansing solutions and / or sensitivity to laxatives or salty tastes, voluntarily agreed to test the new composition of the present invention.No new solution was offered to patients with serious medical problems, heart disease, diabetes, and potentially serious gastrointestinal problems. Successful bowel preparation was achieved in all but one patient (success rate 97.7%), and only one patient did not complete the solution due to transient nausea and vomiting (side effect rate 2.3%). This is better than other well-known commercially available colon cleansing solutions based on previously published results showing an overall success rate of 80% and an overall discomfort rate of 8% (DiPalma JA, The American J Gastro, 104: 2275 -2284, 2009).There were no clinically significant changes in vital signs (blood pressure, heart rate) in connection with the procedure, as well as in the level of hydration or indicators of the chemical composition of the blood. It is particularly important that there are no significant changes in serum chlorine, sodium and bicarbonate levels as a result of taking this lower chlorine composition. Apart from the only patient, as noted above, who experienced some transient nausea, there have been no other reports of stomach cramps, nausea, bloating or vomiting as a result of taking this composition.In general, the composition of the invention was found to be effective, well tolerated, and well accepted in this generally sensitive population.

Example 7

[0058] Exhaled air was collected from 142 patients for hydrogen and methane analysis immediately prior to undergoing routine ambulatory colonoscopy. The patients were previously prepared for examination by taking one of the standard commercially available colon cleansing solutions or compositions according to the invention according to Example 6 above.The comparison results are summarized in Table VI.

Table VI
Exhaled hydrogen and methane levels after taking standard colon cleansers *
Nulytley Movieprep Miralax / Gatorade Invention (2 g of xylitol) Invention (30 g of xylitol)
Number of patients 27 42 31 23 19
H2 range 0-12 0-93 2-44 2-79 2-43
Medium H2 10.4 26.3 20.4 18.0 15.4
CH4 range 0-9 0-56 0-11 0-46 0-13
Average CH4 level 2.6 5.0 2.4 6.1 2.4
Mid.H2 + medium CH4 13.0 31.3 22.9 24.1 17.8
* Exhaled air samples were taken immediately prior to colonoscopy from 142 consecutive patients and exhaled hydrogen and methane levels were determined using a Quintron Breathalyzer and expressed in parts per million (ppm).

[0059] While the preferred embodiments of the present invention have been described above in sufficient detail, it should be understood that those who use the invention for a particular end-use can choose from numerous possible embodiments of the invention.The description of the compositions and method of the present invention is not intended to limit the present invention, but only illustrates it by way of example of preferred embodiments of the invention. Other compositions and methods, which include modifications or changes that have been set forth in the present description of the invention, are equally included in this application. Additional objects, features and advantages of the present invention will become apparent by reference to the foregoing description of the invention.

MODERN EXPERIENCE IN USING TRISULPHATE IN PREPARATION FOR COLONOSCOPY FROM A CLINICAL SAFETY POSITION | Zavyalov

1. Zavyalov D.V., Kashin S.V. Missed colon neoplasias. Coloproctology. 2015; No. 1 (51), pp. 32-37.

2. Knyazev M.V., Shcherbakov P.L., Parfenov A.I.et al. Colon Cleansing Before Colonoscopy: Balancing Efficacy, Safety, and Drug Response. Endoscopic Surgery. 2015; No. 3, p. 30-36.

3. Mtvralashvili D.A., Veselov V.V., Galyaev A.V. et al. Experience in the use of polyethylene glycol preparations for preparation for endoscopic examinations and interventions. General medicine. 2016; No. 3, p. 85-90.

4.Kostenko N.V., Veselov V.V. Domestic preparation of polyethylene glycol in the diagnosis of diseases of the colon. Pharmateca. 2010; No. 20 (213), pp. 72-75.

5. Di Palma JA. A Randomized Clinical Study Evaluating the Safety and Efficacy of a New, Reduced-Volume, Oral Sulfate Colon-Cleansing Preparation for Colonoscopy. Am J Gastroenterol. 2009; 104: 2275-84.

6.Rex DK. A randomized clinical study comparing reduced-volume oral sulfate solution with standard 4-liter sulfate-free electrolyte lavage solution as preparation for colonoscopy gastrointestinal endoscopy. Gastrointest Endosc. 2010 Aug 19; 72 (2): 328-36. Epub 2010 Jun 19.

7. Harrison NM. Bowel cleansing before colonoscopy. World J Gastrointest Endosc. 2016 January 10; 8 (1): 4-12.

8.Lynn Huynh MPH, Yermakov S, Davis M. et al. Cost-analysis model of colonoscopy preparation using split-dose reduced-volume oral sulfate solution (OSS) and polyethylene glycol with electrolytes solution (PEG-ELS). Journal of Medical Economics. 2016; v.19, Issue 4.

9. Fedorov ED, Veselov VV, Kashin SV, Tikhomirova EV, et al. Evaluation of Bowel Preparation with Sulfate-Based Low Volume Preparation versus Macrogol: A Phase 3, Multicenter, Randomized, Comparative Clinical Trial.Russian journal of gastroenterology, hepatology, coloproctology. 2019; No. 29 (2), pp. 60-75.

10. Khitaryan A.G., Kovalev S.A., Romodan N.A. et al. First results of one-step preparation with sulfate-based hyperosmotic saline as a preparatory step for endoscopic examinations and / or colon surgery. Coloproctology. 2019; vol. 18, no. S3 (69), p.103.

11. Pelham RW. A Pharmacokinetics Evaluation of a New, Low-Volume, Oral Sulfate Colon Cleansing Preparation in Patients With Renal or Hepatic Impairment and Healthy Volunteers. J Clin Pharmacol. 2010; 50: 350-354.

12. Pal V. Intestinal and Renal Effects of Low-Volume Phosphate and Sulfate Cathartic Solutions Designed for Cleansing the Colon: Pathophysiological Studies in Five Normal Subjects.The American Journal of Gastroenterology. 2009; v. 104, Issue 4, pp. 953-965. DOI: 10.1038 / ajg.2008.124

13. Cole DE, Thurgood AM, Whiting SJ. Increased serum sulfate after protein loading in adult humans. Can J Physiol Pharmacol. 1991; 69: 25-27.

14. Cole DE, Evrovski J. The clinical chemistry of inorganic sulfate. Crit Rev Clin Lab Sci.2000; 37: 299-344

15. Anastassopoulos K, Farraye FA, Knight T. et al. A Comparative Study of Treatment-Emergent Adverse Events Following Use of Common Bowel Preparations Among a Colonoscopy Screening Population: Results from a Post-Marketing Observational Study. Dig Dis Sci. 2016; 61 (10): 2993-3006.

16. Moulin B, Ponchon T. A comparative review of use of sulphate and phosphate salts for colonoscopy preparations and their potential for nephrotoxicity.Endosc Int Open. 2018; 6 (10): E1206-E1213. doi: 10.1055 / a-0581-8723

17. Smith JM, Lowe RF, Fullerton J et al. An integrative review of the side effects related to the use of magnesium sulfate for preeclampsia and eclampsia management. BMC Pregnancy Childbirth. 2013; 13:34

18. Saltzman JR, Cash BD, et al. ASGE Standards of Practice Committee.Bowel preparation before colonoscopy. Gastrointest Endosc. 2015; 81: 781.

19. DA – Food and Drug Administration. Electronic resource: https://gmpnews.ru/terminologiya/fda/ (date of treatment 05/29/2020)

20. Hassan C, East J, Radaelli F, et al. Bowel preparation for colonoscopy: European Society of Gastrointestinal Endoscopy (ESGE) Guideline – Update 2019.Endoscopy. 2019; 51 (8): 775-794. doi: 10.1055 / a-0959-0505

21. Instructions for medical use of the drug “Eziklen”.

X-ray department

Khudoley Dmitry Vladimirovich

Head of the X-ray department, doctor of the highest qualification category

About the branch

Currently, the X-ray department of the KGBUZ “City hospital No. 4, g.Barnaul “is equipped with modern diagnostic equipment. The hospital has two X-ray diagnostic rooms equipped with modern remote-controlled X-ray machines. The polyclinic has a fluorography room equipped with a digital device “Electron” and a densitometry room.

In addition to such research methods as fluoroscopy, radiography, fluorography, the department performs a wide range of special techniques:

– lung tomography;
– intravenous urography;
– double contrasting of the gastrointestinal tract;
– hysterosalpingography;
– fistulography;
– proctography;
– special pictures of the skull;
– examination of the intestine according to Velin, etc.etc.

Preparation of patients and X-ray examinations of the stomach and small intestine

Patients with normal bowel function do not require any special preparation for X-ray examination of the stomach.
In case of pathology of the stomach and intestines, preparation of patients and X-ray examinations of the stomach and small intestine are needed
Patients with normal bowel function do not require any special preparation for X-ray examination of the stomach.The study is carried out on an empty stomach.
If there is a large amount of fluid, mucus, food debris in the patient’s stomach (for example, with an organic narrowing of the outlet of the stomach), the stomach should be flushed 2-3 hours before the examination.
With pronounced flatulence and persistent constipation, a cleansing enema is recommended 1.5-2 hours before the study.

Preparation for irrigoscopy
For X-ray examination of the colon – irrigoscopy (lat.irrigatio – irrigation) – complete cleansing of the intestines from contents and gases is necessary. Radiopaque substance up to 1.5 liters of warm (36–37 ° C) suspension of barium sulfate is injected into the intestine using an enema directly in the X-ray room.

Contraindications to irrigoscopy: diseases of the rectum and its sphincters (inflammation, swelling, fistula, sphincter fissure). There are situations when the patient cannot keep the fluid injected in the intestine (prolapse of the rectum, weakness of the sphincter), which makes this procedure impracticable.

Stages of patient preparation for research:
• Prescribed 2-3 days before the study on a diet that excludes foods rich in plant fiber and other substances that contribute to increased gas production. It is necessary to exclude fresh rye bread, potatoes, legumes, fresh milk, fresh vegetables and fruits, fruit juices from the diet.
• On the eve of the study, the patient is prescribed a light supper (no later than 8 pm). Omelet, kefir, caviar, cheese, boiled meat and fish without seasonings, tea or coffee without sugar, semolina boiled in water are allowed.
• On the eve of the study, before lunch, the patient is given 30 g of castor oil for ingestion (a contraindication to taking castor oil is intestinal obstruction).
• The night before (30–40 minutes after dinner), the patient is given cleansing enemas with an interval of 1 hour until “clean” wash water is obtained.
• In the morning, 2 hours before the examination, the patient is given a cleansing enema also before receiving “clean” rinsing water.
• The study is carried out on an empty stomach.If necessary, according to the doctor’s prescription, the patient is allowed a light protein breakfast in the morning (low-fat cottage cheese, whipped protein soufflé or protein omelet, boiled fish), which allows you to cause a reflex movement of the contents of the small intestine into the large intestine and prevent the accumulation of gases in the intestine. In this case, the morning cleansing enema is applied 20-30 minutes after breakfast.

Oral lavage is another way to cleanse the intestines before X-ray and endoscopic examination.For its implementation, iso-osmotic solutions are used, for example, Fortrans. Fortrans packaging, intended for one patient, consists of four bags containing 64 g of polyethylene glycol in combination with 9 g of electrolytes: sodium sulfate, sodium bicarbonate, sodium chloride and potassium chloride. Each bag is dissolved in 1 liter of boiled water. As a rule, the patient is prescribed to take the first 2 liters of solution after lunch on the day preceding the study; the second portion in the amount of 1.5-2 liters is given in the morning of the study day.The effect of the drug (bowel emptying) is not accompanied by pain and tenesmus, begins 50–80 minutes after the start of the solution and lasts for 2–6 hours. When Fortrans is reappointed in the morning, bowel emptying begins 20–30 minutes after taking the drug. The use of Fortrans is contraindicated if the patient has nonspecific ulcerative colitis, Crohn’s disease, intestinal obstruction, and abdominal pain of unknown etiology.

Preparing a patient for X-ray examination of the kidneys
For two days before the study, food is given to reduce flatulence, fermentation in the intestines;
– raw vegetables, fruits, black bread, jelly, compotes are excluded;
– limit dairy products, sugar;
– in the evening on the eve and in the morning, 2 hours before the study, a cleansing enema is done;
– before the examination, the patient must completely empty the bladder.
– breakfast is obligatory before the exploration.
Note. During the preparation of the patient for the study and in the process of carrying it out, medicinal, physiotherapeutic and other medical procedures are canceled to avoid distortion of the results.
Note. When a contrast agent is injected a day before the study, a test is carried out for the tolerance of this contrast agent: 0.5-1.5 mg of a contrast agent diluted in 5-10 ml of 0.9% sodium chloride solution is injected intravenously.In the absence of allergies (rash, headache, nausea, vomiting, etc.), a study is carried out.

Fortrans powder for solution preparation inside 64g pack. 4 units

Elderly persons with poor health are advised to use the drug only under the supervision of medical personnel.

Solid food should be avoided for at least two hours before using Fortrans® and until the end of the examination.Drinks such as tea, coffee (no milk) and other non-alcoholic beverages are allowed.

The patient must maintain an interval of at least 1 hour between taking Fortrans® and other medications.

The preparation contains Macrogol 4000 (polyethylene glycol). Allergic reactions (anaphylactic shock, angioedema, urticaria, skin rashes) have been reported after administration of drugs containing polyethylene glycol.

Care must be taken when prescribing Fortrans® to patients with inflammation of the intestinal mucosa, including the rectum.

The drug should be used with caution and only under the supervision of medical personnel in patients with a tendency to aspiration, in bedridden patients, in patients with neurological disorders and / or in patients with motor impairment due to the risk of aspiration pneumonia. For such patients, the drug is administered in a sitting state and through a nasogastric tube.

Patients in a semi / unconscious state should be carefully monitored during the use of the drug.If symptoms of pain or bloating appear, the rate of administration of the drug should be reduced or the application should be suspended until these symptoms disappear.

Due to the isotonic composition of Fortrans®, patients are not expected to develop electrolyte imbalance after taking it, with the exception of patients at risk of water-electrolyte imbalance. Patients with imbalances in water and electrolyte balance need to undergo appropriate therapy to eliminate them before carrying out the bowel cleansing procedure.The drug should be used with caution in patients prone to the development of water-electrolyte imbalance, including hyponatremia and hypokalemia, as well as in patients who have a higher risk of side effects (in patients with impaired renal function, heart failure, or in patients with concomitant diuretic therapy). The use of the drug in these patients should be carefully monitored.

Particular care must be taken in patients with heart and renal failure, as they are at risk of developing acute pulmonary edema due to fluid overload.The experience of medical use of the drug in patients with impaired renal function is limited.

The efficacy and safety of Fortrans® in children under the age of 18 has not been established.

INFLUENCE ON THE ABILITY TO DRIVE A CAR AND WORK WITH MECHANISMS

Not installed.

However, given the pharmacological effect of the drug and the potential for adverse reactions, care should be taken when driving and operating machinery.

Preparation of the intestine for colonoscopy with a low-volume solution of polyethylene glycol with ascorbic acid (Moviprep®)

Article in PDF format.

Colonoscopy remains the gold standard for colon imaging and the primary screening method for colorectal cancer. The effectiveness and safety of this procedure depends on the quality of the bowel preparation.With inadequate cleansing of the latter, even large neoplasms can be missed; in addition, the risk of perforation increases. Ideal preparation should ensure complete cleansing of the intestine from feces without changing the macro- and microscopic appearance of the mucous membrane, not causing significant changes in the water-electrolyte balance, not require significant time and be comfortable for the patient.

Preparations based on chemically inert polymer of macrogol (polyethylene glycol; PEG) – isoosmotic solution, which, passing through the intestine, is not absorbed and does not stimulate secretion, have established themselves as drugs with a high safety profile, including in patients with electrolyte disorders, severe hepatic dysfunction, congestive heart failure, acute and chronic renal failure.Another major advantage of macrogol is that it does not alter the histological picture of the mucous membrane and can be used in patients with suspected inflammatory bowel disease.

Macrogol preparations are usually prescribed in the form of a 4 L solution to obtain an adequate cleansing effect. However, such a large volume of fluid impairs the tolerance of the preparation and reduces the patient’s compliance. To eliminate this disadvantage, Moviprep ® was developed as an effective alternative, also used in the form of a solution (2 L), which, along with macrogol, contains ascorbic acid (AA), sodium sulfate and electrolytes.A number of studies have demonstrated that Moviprep ® provides the same or better bowel preparation quality and better tolerance compared to conventional PEG formulations. Among such works is a randomized controlled trial conducted by scientists from Italy (F. Valiante et al., 2012).

The study included patients who were scheduled for colonoscopy for routine indications. Participants were randomized 1: 1 for bowel preparation using Moviprep ® (2 L PEG + AA group) or Isokolan (4 L PEG group).1 liter of Isokolan solution contains 58.3 g of macrogol 4000, 2.84 g of sodium sulfate, 0.84 g of sodium bicarbonate, 0.73 g of sodium chloride and 0.37 g of potassium chloride. 1 liter of Moviprep ® solution contains 100 g of macrogol 3350, 7.5 g of sodium sulfate, 2.7 g of sodium chloride, 1 g of potassium chloride, 4.7 g of AA and 5.9 g of sodium ascorbate.

The endoscopist or nurse provided the patient with written instructions on how to prepare and consume the test solutions and diet (following a low fiber diet for 3 days and a liquid diet for 1 day).In the 4 L PEG group, patients received 2 L of solution between 15:00 and 17:00 and another 2 liters between 18:00 and 20:00 (250 ml every 15 minutes). In the 2 L PEG + AA group, patients took 2 L of the solution between 17:00 and 20:00 (250 ml every 15 minutes) and 500 ml of clear liquid for each liter of the drug solution.

Colon cleansing was considered adequate at a score of 1-3 on the Aronchik scale and inadequate at a score of 4-5 (Table 1).

Patients knew which drug was being used, but were instructed not to share this information with the endoscopist.Prior to the procedure, a non-endoscopic physician interviewed patients for adherence and tolerance to the bowel preparation regimen. Compliance was defined as ≥75% fluid intake. Tolerance was assessed on a 5-point Likert scale (1 – very high, 2-3 – high, 4-5 – low).

Colonoscopy was scheduled between 8:30 am and 2:00 pm on the day following preparation. The study was carried out by experienced endoscopists (> 5000 procedures) using an EVIS EXERA II CF-Q154I video colonoscope (Olympus).After the procedure, endoscopists assessed the quality of colon cleansing.

339 patients were randomized (ITT population; intention-to-treat). Seven patients refused to undergo colonoscopy; As a result, the PP-population (per protocol) was 332 patients – 166 in each group.

The groups were comparable in terms of clinical and demographic characteristics. The average age of patients in the 2 L PEG + AA and 4 L PEG groups was 63 and 65 years, respectively. About a third of patients underwent colonoscopy to screen for colorectal cancer; in other cases, the procedure was performed for the first time for various indications (bleeding, change in the frequency of bowel movements, anemia, or abdominal pain).

Bowel preparation was adequate in 143 (ITT 84.6%; PP 86.2%; p = 0.04) patients in the 2 L PEG + AA group and 128 (ITT 75.3%; PP 77%) patients in the 4 L group PEG. Table 2 shows the distribution of scores according to the Aronchik scale in different segments of the colon.

Compliance (ingestion ≥75% of the solution volume) was 100% in the 2 L PEG + AA group and 98% in the 4 L PEG group (p = 0.7).

Adverse reactions were observed in 17% of patients in the 2 L PEG + AA group and in 20% of patients in the 4 L PEG group (p = 0.4).In the 2 L PEG + AA group, nausea, vomiting, and abdominal pain were less common; however, the difference between groups was not statistically significant.

According to the patients’ assessment, bowel preparation with 2 L of PEG + AA was significantly better tolerated than that of 4 L of PEG (good or very good tolerance – 83 and 76%, respectively; p = 0.02; Table 3).

Thus, the results of this study showed that low-volume bowel cleansing (2 L of PEG + ASA) was more effective (in the ITT analysis) and better tolerated compared to the regimen for which PEG-based preparations are usually used.

In terms of compliance, the groups did not differ statistically, which may be due to the need for an additional intake of 1 L of clear liquid in the 2 L PEG + AA group. Accordingly, the higher quality of bowel cleansing when using Moviprep ® can, at least in part, be explained by the laxative effect of AA. This is consistent with the results of the L.B. Cohen et al. (2010), which demonstrated the advantage of introducing 2 L of PEG + AA as compared to that of 2 L of PEG without AA.

As with other studies, the 2 L PEG + AA bowel cleansing regimen was safe with no serious side effects. It should be emphasized that PEG formulations are generally safer than sodium phosphate formulations. Sodium phosphate bowel cleansing regimens have been associated with an increased incidence of electrolyte disturbances and neurotoxicity.

The better tolerance to 2 L of PEG + AA can be explained by the lower total volume of the prescribed liquid (2 + 1 L versus 4 L; it is obvious that an additional liter of clear liquid is easier to drink than a liter of PEG solution) and the pleasant taste of ascorbic acid.According to the authors, the tolerance of bowel preparation with a low-volume PEG solution can be improved even more by using a split dosing regimen: the first liter of the diluted preparation is taken in the evening, and the second – in the morning on the day of the colonoscopy. In addition, in the study by R. Marmo et al. (2010), the use of 2 L of PEG + AA according to this scheme was significantly more effective than taking 4 L of PEG without AA on the eve of the procedure.

In conclusion, it should be noted that improving the tolerance of bowel cleansing does not directly affect the safety and efficacy of colonoscopy (i.e.(i.e., the incidence of neoplasia), but it can be critical for the long-term adherence of patients to screening for colorectal cancer: according to numerous studies, many patients refuse colonoscopy primarily because of the need for bowel preparation.

Adapted from: Valiante F. et al. A randomized
controlled trial evaluating a new 2-L PEG solution plus ascorbic acid
vs 4-L PEG for bowel cleansing prior to colonoscopy. Dig Liver
Dis.2012 Mar; 44 (3): 224-7.

Prepared by Alexey Tereshchenko

With the assistance of Takeda Ukraine LLC

UA / XMP / 0617/0044

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Preparations of macrogol in the preparation of patients for colonoscopy and surgical interventions | Grigorieva G.A., Golysheva S.V.

It is difficult to overestimate the urgency of the problem of bowel cleansing when preparing patients for endoscopic, X-ray examinations and bowel surgery. For many years, there has been a search for a simple and effective method for cleansing the colon, the use of which would increase the reliability of the research results and would allow avoiding postoperative complications associated with poor bowel cleansing. In the 70s of the last century, for these purposes, intestinal cleansing with non-absorbable solutions began to be used [1,2].This technique replaced the previously used standard preparation, which included a diet low in toxins, laxatives and enemas. However, the widespread use of the new method was limited by side effects caused by the hyperosmolarity of solutions used per os [3].

The ability to use isoosmotic solutions for complete cleansing of the intestines appeared in 1980. Their use reduced the frequency of side effects, but nevertheless did not receive wide distribution again due to the unpleasant (salty) taste of the solution and the feeling of nausea when taken [4,5,6] …Recently, a new iso-osmotic agent Isosolan has been shown to be a well-tolerated bowel cleansing agent, according to some reports, reflecting the results of a number of open multicenter studies [8]. But the experience of its application has not yet been accumulated.
Thus, the search for drugs that can improve bowel cleansing and not cause discomfort in patients has continued all these years.
In 1980 Davis and Fordtran et al. [4,8], based on previous experiments, came to the conclusion about the need to develop a new solution that does not have the ability to be absorbed in the intestine and cause the secretion of water and electrolytes.For this purpose, various combinations of salts have been studied. As a result, the researchers came to the decision to use sodium sulfate as a basic salt in solution (since it is not absorbed in the intestine) in combination with other salts (Na2SO4, KCL, NaHCO3). An osmotic agent not absorbed in the intestine, polyethylene glycol (PEG) 4000, was found, studied and included in the newly created solution. Macrogol (PEG 4000), due to its high molecular weight, was not absorbed from the gastrointestinal tract and was not metabolized, prevented the absorption of water from the stomach and intestines and contributed to the accelerated evacuation of intestinal contents.Electrolytes, in turn, prevented the disruption of the body’s water-electrolyte balance. In the final version, the resulting solution had the following composition (per 1 liter): NaCl – 25 mmol, Na2SO4 – 40 mmol, KCl – 10 mmol, NaHCO3 – 20 mmol, PEG 4000 – 16 mmol.
Subsequent clinical studies confirmed the effectiveness of the new method and proved its advantages over previously used methods. So, in one randomized blind clinical study, conducted with the aim of comparing the effectiveness of the new (PEG 4000) and standard (non-slag diet + laxatives + enema) methods of cleansing, two criteria were used: 1) the absence of residual fecal masses in the intestine; 2) the percentage of a complete examination of the colon mucosa.It turned out that the use of the solution with PEG 4000 was significantly more effective than using the standard method (p
Despite the fact that the patients generally tolerated the PEG 4000 intake satisfactorily, some unpleasant symptoms still remained. The salty taste of the solution caused the patients to limit their intake of sufficient fluids and, apparently, was the cause of nausea (13% of cases) and vomiting (11% of cases). To eliminate these shortcomings, a drug was developed that appeared on the market under the trade name Fortrans.
Fortrans has a composition similar to that proposed by Davis and Fordtran et al. A convenient form of release of the drug is small sachets weighing 73.6 g each, containing a white powder that is easily soluble in water. It included: macrogol (polyethylene glycol 4000) – 64 g, anhydrous sodium sulfate – 5.7 g, sodium bicarbonate – 1.68 g, sodium chloride – 1.46 g, potassium chloride – 0.75 g, sodium saccharin – 0.1 g. Weight of one sachet 73.69 g.
Thus, over the decades, various methods of bowel cleansing have been consistently developed and modified for diagnostic and therapeutic endoscopic examinations and surgical interventions.Some of them are reflected above.
Currently, both in our country and abroad, the technique of bowel cleansing with the help of Fortrans is widely used, which I would like to dwell on in more detail, since we have two years of experience in its application.
According to the program proposed by the developers, published in a handbook accessible to every specialist (Vidal 2004), the contents of one sachet dissolve in one liter of water. The dose of the drug is set at the rate of one liter of the prepared solution per 15–20 kg of the patient’s body weight, which corresponds to 3-4 liters of the drug solution required to prepare for the study.The solution is suggested to be taken in 200 ml every 20 minutes in the evening on the eve of the study. The attractiveness of the method for the patient is its simplicity: a slag-free diet and cleansing enemas are excluded, the preparation does not require the help of medical personnel. The doctor gets the opportunity to examine the entire colon in a short period of time and with high reliability of the results obtained. However, not all patients tolerate large amounts of fluids in a short period of time well.In the process of taking the drug, some people experience nausea, vomiting, a feeling of heaviness and discomfort in the abdomen. This is especially true for patients with severe concomitant diseases. The desire to optimize the standard bowel preparation method using Fortrans was reflected in a number of foreign publications [9,10,11]. There were proposals to use the method fractionally, appointing Fortrans in equal parts the morning before and on the day of the study 3-4 hours before the required procedure. O.A. Paoluzi et al.applied a different regimen of solution intake: two liters in the afternoon the day before and one liter in the morning on the day of the study. Colon lavage was well tolerated by patients and had a lower incidence of side effects than with other research methods. We, based on our observations, also believe that the fractional regimen of solution intake is more effective. It allows you to extend this method to a wide group of people, including patients with concomitant diseases.
The question of the preparation of patients with severe heart failure and erosive and ulcerative lesions of the intestine, for whom the intake of a large volume of solution, even in fractional mode, is practically unacceptable, remains unresolved.At the same time, it is known, for example, that patients with ulcerative colitis and Crohn’s disease need frequent endoscopic examinations both to monitor the dynamics of the inflammatory process and to detect early signs of malignancy (a group at risk of developing colon cancer in ulcerative colitis). To prepare this contingent of patients, we use Forlax, an osmotic laxative intended for the symptomatic treatment of constipation in adults. Forlax contains: as an active substance – macrogol 4000 (10 g in one sachet), sodium saccharin and orange-grapefruit flavor.Macrogol retains water molecules in the intestinal lumen using hydrogen bonds, which leads to an increase in the volume of intestinal contents and increased peristalsis. Unlike Fortrans, a Forlax sachet dissolves not in one liter, but in 250 ml of water. Since the laxative effect of Forlax occurs after 24–48 hours, the drug is prescribed by us either two sachets a day in the morning with meals during the three days preceding the procedure, or two sachets in the morning and evening (depending on the patient’s condition).During this period of time, the proximal intestines are gradually released. To cleanse the distal sections, one small cleansing enema is given on the morning of the study day. With this preparation, nausea, vomiting, any abdominal discomfort and severe diarrhea were not observed. In some cases, the cleansing enema was replaced with a half dose of Fortrans solution taken by the patient on the eve of the study.
Since Forlax does not contain sugar, it can be prescribed for patients with diabetes mellitus, as well as for patients whose diet requires the elimination of galactose.
Of course, the method we used is somewhat more complicated, but it makes it possible to prepare gradually and without side effects of patients with severe pathology where the use of other methods is excluded.
The above analysis of the methods of preparing patients for endoscopic, X-ray examinations of the intestines and surgical interventions allows, first of all, to note the urgency of this problem. Until recently, bowel cleansing, necessary for colonoscopy and bowel surgery, was achieved using tedious methods for the patient.For many years, attempts have been made to develop a method that gives the maximum degree of bowel cleansing and is quite acceptable for the patient. The creation and introduction into clinical practice of solutions containing polyethylene glycol 4000 should be considered as a serious success in solving the problem. Naturally, the preparation method with macrogol preparations will be improved. It is already proposed to introduce a fractional Fortrans reception mode. Our analysis of the results of foreign studies in recent years and the experience of our own two-year observations indicate that the fractional method of taking Fortrans causes intestinal distension to a lesser extent than the simultaneous administration of the drug, and is much easier to tolerate by patients.This achieves the same degree of preparation of the colon [10,11].

Literature
1. Crapp A.R., Tillotson P., Pwis SIA, Cook WT, Alexander – Williams J. Preparation of the bowel by whole – gut irrigation. Lancet 1975; 2: 1239-1240.
2. Levy A.G., Benson J.W., Hewlett E.L., Herdt J.R., Doppman J.L., Gordon R.S. Jr. Saline lavage: a rapid, effective and acceptable method for cleansing the gastrointestinal tract. Gastroenterology 1976; 70: 157-161.
3. Chung R.S., Gurll N.J., Berglund E.M. A controlled clinical trial of whole gut lavage as a method of bowel preparation for colonic operations. Am J Surg 1979; 137: 75-81.
4. Davis G.R., Santa Ana C.A., Morawski S.G., Fordtran J.S. Development of a Lavage solution associated with minimal water and electrolyte absorption or secretion. Gastroenterology 1980; 78: 991-995.
5. Di Palma J.A., Brady C.E., Stewart D.L. et al. Comparison of colon cleansing methods in preparation for colonoscopy.Gastroenterology 1984; 86: 856-860.
6. Ernstoff J.J., De Grasia A.H., Marshall J.B., Jumshyd A., McCullough A.J. A randomized blinded clinical trial of a rapid cjljnic lavage solution (Golytely) compared with standard preparation for colonoscopy and barium enema. Gastroenterology 1983; 84: 1512-1516.
7. Fordtran J.S., Santa Ana C.A., Cleveland M. A low-sodium solution for gastrointestinal lavage. Gastroenterology 1990; 98: 1-16.
8. Gastrointest End 1990; 36: 285-289.uso di ISO – GIULIANI nell preparazione alla colonoscopia. Giorn Ital End Dig 1991; Atti 14 Cong. Naz. SIED, 139-140.
9. Lirzin P., Salas H., Dahlab M.R. Colonic preparation with FORTRANS: Singlr dose or two half – doses? Acta Endoscopica, 1989, p. 19.
10. Paoluzi O.A., Maria Carla di Paolo, Ricci F., Pasquali C., Zarug S., F de Libero, Paoluzi P. A randomized controlled trial of new PEG – electrolyte solution compared with a standard preparation for colonoscopy. Ital J Gastroenterol 1993; 25: 174-178.
11. Rey J.F., Soquet J.C. Acceptability of the colonic preparation. The interest in fractioning Fortrans doses for a better preparation to colonoscopy. Medecine et Chirurgie Digestives 1990; 19: 501-517.

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Clinical Study Colon Cleansing in Preparation for Colonoscopy: FE 999169, Niflec – Clinical Trials Register

Inclusion Criteria:

– Patients from Japan, ages 20 to 80 inclusive, requiring a colonoscopy

– Female patients must be postmenopausal (women ≥45 years of age without a menstrual cycle).for at least 12 months with no alternative medical reason) or surgically sterile or use medically approved contraception for the entire trial period.

– Fertile patients must have a confirmed negative pregnancy test at screening and randomization

– Patients must have more than 3 spontaneous bowel movements per week. before colonoscopy

– Written informed consent obtained before any procedure related to the study

Exclusion criterion:

– Acute surgical diseases of the abdominal cavity, such as acute intestinal obstruction or intestinal perforation, diverticulitis, appendicitis.If bowel obstruction and perforation is suspected, conduct appropriate diagnostic investigations to rule out these conditions

– Active (acute / exacerbation / severe / uncontrolled) inflammatory bowel disease (IBD)

– Any prior colorectal surgery except appendectomy, hemorrhoid surgery previously endoscopic procedures

– Colon diseases (history of colon cancer, toxic megacolon, idiopathic pseudo-obstruction, hypomobility syndrome)

– Gastrointestinal disorders (active ulcer, outlet obstruction, gastric retention, gastroparesis) 9000 – Ascites.