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A study comparing the effectiveness of a simeticone drug combination and a sodium picosulfate drug combination for bowel preparation in patients undergoing colorectal cancer screening.

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study aims to compare the effectiveness of two different bowel preparation solutions used before a colonoscopy, which is a medical procedure where a doctor uses a small camera to look inside the large intestine to help with colorectal cancer early detection. One solution being tested is Clensia, which contains simeticone, potassium chloride, sodium chloride, sodium citrate, sodium sulfate anhydrous, macrogol 4000, and citric acid. The other solution is CitraFleet, which contains sodium picosulfate, magnesium oxide, and citric acid. These liquids are taken orally to clear the bowel of waste so that the doctor can clearly see the lining of the intestine.

During the study, participants will be assigned to one of the two treatment groups to receive either Clensia or CitraFleet. The goal is to determine which preparation better allows the doctor to find adenomas, which are small growths on the lining of the colon that can potentially become cancer, and polyps, which are other types of growths found in the intestine. The study will also look at how well the bowel is cleaned and how much gas or bubbles are present during the procedure, as these can make it harder for the doctor to see clearly.

The process involves taking the assigned liquid before the medical procedure and then undergoing the colonoscopy. Information will be collected regarding how easy or pleasant the liquid was to drink and any side effects experienced, such as nausea, vomiting, or abdominal pain. The study evaluates how successfully the doctor can reach the end of the large intestine, known as the cecum, and how much time is needed to complete the examination.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Participation in the study
After joining the study, one of two different bowel preparation solutions will be assigned to be used before the colonoscopy (a procedure where a camera is used to look inside the large intestine).
The assigned solution will be either clensia or citrafleet.
Step 2
Administration of the preparation solution
If clensia is assigned, 112.66 grams of the powder for oral solution will be consumed to clean the bowel.
If citrafleet is assigned, 30.16 grams of the powder for oral solution will be consumed to clean the bowel.
Step 3
Colonoscopy procedure
A colonoscopy will be performed to check for adenomas (small growths in the lining of the colon) or polyps (small growths on the lining of the colon).
During this procedure, the effectiveness of the cleaning will be measured by looking for bubbles or foam and checking the quality of the bowel cleaning using specific scales.
Step 4
Assessment of the experience
After the procedure, several factors regarding the bowel preparation will be recorded, including how easy it was to drink, how the taste was, and the overall satisfaction with the process.
Any adverse events, which are side effects like nausea, vomiting, abdominal pain, bloating, headache, chills, dizziness, or dry mouth, will be noted.

Who can join the trial?

6 criteria

Both men and women between the ages of 50 and 69.
Individuals who are already part of the early detection program for colorectal cancer (a program designed to find cancer in the large intestine before it becomes serious).
A positive result from a fecal occult blood test, which is a test that looks for hidden blood in the stool that cannot be seen with the naked eye.
The blood level in the stool must be 20 μg Hb/g feces or higher (this measures the amount of hemoglobin, a protein in red blood cells, present in the sample).
People who are already scheduled to have a screening colonoscopy (a medical procedure where a doctor uses a tiny camera to look inside the large intestine to check for health issues) at the Hospital Clínic de Barcelona.
Participants must sign an informed consent form, which is a document that explains all the details of the study so you can agree to take part.

Who cannot join the trial?

16 criteria

Having severe kidney failure, which is a condition where the kidneys cannot filter waste from the blood properly.
Having congestive heart failure, a condition where the heart cannot pump blood effectively enough to meet the body's needs.
Having hypermagnesemia, which means there is too much magnesium in the blood.
Having rhabdomyolysis, a condition where damaged muscle tissue releases a protein into the blood that can harm the kidneys.
Having phenylketonuria, a rare disorder that causes an inability to break down a specific amino acid.
Having glucose-6-phosphate dehydrogenase deficiency, a genetic condition that can cause red blood cells to break down too quickly.
Having an allergy or hypersensitivity to the active ingredients or other substances used to make the study medicine.
Being pregnant or breastfeeding.
Having had a colonoscopy, which is a medical procedure to look inside the large intestine, within the last year.
Having a very low Barthel Index score, which is a measure of how much help a person needs with daily activities, combined with functional constipation, which is a type of chronic difficulty with bowel movements.
Having a mental disability or severe mental disorder, such as schizophrenia, severe depression, or bipolar disorder.
Being unable to understand spoken or written Catalan or Spanish.
Having had part or all of the colon removed through surgery.
Having a personal history of colorectal cancer or other colon diseases that require special monitoring, such as ulcerative colitis or Crohn's disease.
Having a terminal illness or a serious illness or disability that would make it unsafe or impossible to undergo the study procedures.
Having gastrointestinal disorders that prevent the use of the study products, such as problems with how the stomach empties, a hole in the digestive tract (perforation), a blockage (obstruction), a lack of movement in the intestines (ileus), or severe swelling of the colon (toxic megacolon).

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Hospital Clinic De Barcelona
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Barcelona, Spain

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Investigated drugs

Clensia
is an oral powder that is mixed with water to create a solution used to clear out the bowels before a medical procedure. It contains ingredients that help soften the stool and reduce gas, making it easier to clean the colon for a thorough examination.
CitraFleet
is an oral powder that is mixed with water to create a solution used to empty the bowels. It contains ingredients that act as a laxative to help clear out the digestive tract so that doctors can clearly see the inside of the colon during a colonoscopy.

Sodium Sulfate Anhydrous

What is already known about the treatment

Clensia
This medication is an oral powder that is mixed with water to create a solution for drinking. It is a widely used bowel preparation product that helps clear the intestines before medical procedures like colonoscopies. It works by combining a substance that breaks up gas bubbles with ingredients that pull water into the gut, which softens the stool and helps it pass easily. This mixture is classified as an osmotic laxative and an anti-foaming agent.
CitraFleet
This medicine is provided as a powder that must be dissolved in water and taken by mouth. It is commonly used in medical settings to prepare the digestive tract for internal examinations. The medication works by stimulating the bowel muscles and using minerals to draw extra liquid into the intestines, which helps flush out waste. It is classified as a stimulant and osmotic laxative combination.

Investigated diseases

Colorectal cancer - This is a type of cancer that starts in the colon or the rectum. It often begins as small, noncancerous growths called polyps on the inner lining of the digestive tract. Over time, some of these polyps can undergo changes that turn them into malignant tumors. As the disease progresses, these tumors can grow larger and may invade nearby tissues. The condition can also spread to other parts of the body through the bloodstream or lymphatic system.