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Effectiveness of Macrogol 3350 With Electrolytes and Sodium Picosulfate/Magnesium Citrate Combination for Bowel Preparation in Patients With Inadequate Previous Colonoscopy Preparation

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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 evaluate the effectiveness of a combination of macrogol 3350 with electrolytes (CLINITRAT) and sodium picosulfate/magnesium citrate (PICOPREP) for bowel preparation before a colonoscopy. A colonoscopy is a procedure where a flexible tube with a camera is used to examine the inside of the large intestine (colon). Proper bowel preparation is essential for a successful colonoscopy, as it allows the doctor to clearly see the intestinal walls.

The study focuses on patients who previously had inadequate bowel preparation during a reference colonoscopy, as measured by the Boston Bowel Preparation Scale (BBPS). The research will determine if this combination of medications provides better cleansing of the intestine compared to a placebo. The effectiveness will be measured by looking at the overall BBPS score, specific scores for different parts of the colon, the rate of polyp detection, and how often the colonoscopy successfully reaches the cecum (the beginning of the large intestine).

Participants in the study will be adults who had insufficient bowel preparation in a previous colonoscopy. The study will also assess how well patients tolerate the preparation regimen through a questionnaire. Good bowel preparation is defined as achieving specific BBPS scores that indicate the colon is clean enough for a thorough examination.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Starting the Clinical Trial

    After joining the study, you will be randomly assigned to receive either CLINITRAT (6.563+175,4+89,3+23,3) mg/sachet (containing sodium hydrogen carbonate, potassium chloride, sodium chloride, and macrogol 3350) or a placebo that looks identical but does not contain the active ingredients.

    This study is for patients who previously had a colonoscopy with inadequate bowel preparation (scored less than 6 points on the Boston Bowel Preparation Scale).

  2. Step 2

    Preparation for Colonoscopy

    You will receive instructions to take either CLINITRAT or the placebo along with PICOPREP (sodium picosulfate/magnesium citrate) as preparation for your upcoming colonoscopy.

    This combination is being tested as a second-line treatment for colonoscopy preparation, specifically for patients who had inadequate preparation in their previous colonoscopy.

  3. Step 3

    Taking the Medication

    You will take the medication orally as a solution. The CLINITRAT powder (or placebo) must be dissolved in water before drinking.

    Detailed instructions about when to take the medication, how much water to mix it with, and dietary restrictions will be provided to you before the procedure.

  4. Step 4

    Undergoing Colonoscopy

    You will undergo a colonoscopy procedure where the doctor will evaluate how well your bowel was prepared.

    The quality of your bowel preparation will be scored using the Boston Bowel Preparation Scale (BBPS), which rates how clean each section of your colon is.

  5. Step 5

    Post-Procedure Assessment

    After the colonoscopy, you will complete a questionnaire about how well you tolerated the bowel preparation process.

    The doctors will record information about your procedure, including whether they reached the cecum (first part of the colon) and if they detected any polyps (abnormal tissue growths).

  6. Step 6

    Completion of the Trial

    Your participation in the study will end after the colonoscopy and completion of the tolerance questionnaire.

    The study is scheduled to run until June 2025, with final results expected by June 2027.

Who can join the trial?

5 criteria

  • You must be at least 18 years old
  • You must have had a previous colonoscopy with inadequate bowel preparation (scored less than 6 points on the Boston Bowel Preparation Scale, which is a tool doctors use to assess how clean your colon was during the procedure)
  • You must be legally competent and able to understand information provided about the study
  • You must voluntarily agree to participate in the study
  • You must sign the informed consent form after being informed about the nature, scope, and purpose of the study

Who cannot join the trial?

11 criteria

  • You cannot join the study if you are under 18 years old or over 85 years old
  • You cannot participate if you are pregnant or breastfeeding
  • If you have heart failure (where your heart cannot pump blood effectively), you cannot join the study
  • If you have kidney failure (when your kidneys don't work properly to filter waste from your blood), you are excluded
  • People with a bowel obstruction (blockage in the intestines) cannot participate
  • If you have an ileostomy (a surgical opening in the abdomen where the small intestine is brought outside the body), you cannot join
  • Those with inflammatory bowel disease (chronic inflammation of the digestive tract) are excluded
  • If you have severe colitis (serious inflammation of the colon), you cannot participate
  • You cannot join if you have a toxic megacolon (dangerous enlargement of the colon)
  • If you are allergic to any ingredients in the study medications, you cannot participate
  • If you cannot understand the study or give informed consent, you cannot join
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Investigated drugs

  • Macrogol 3350 and electrolytes

    is a laxative medication that helps clean out the bowels before a colonoscopy. It works by drawing water into the intestines, which softens the stool and stimulates bowel movements. This medication is being studied as part of a combination treatment for patients who had inadequate bowel preparation in a previous colonoscopy.

  • Sodium picosulfate/magnesium citrate

    (PICOPREP) is another type of bowel cleansing medication that works by stimulating the intestinal wall and drawing water into the bowel to clear it out. This medication is commonly used before colonoscopies to ensure the doctor can clearly see the inside of the colon.

What is already known about the treatment

  • Macrogol 3350 with electrolytes

    This medication is administered orally as a powder that is dissolved in water and consumed as a solution for bowel cleansing before colonoscopy procedures. It is widely recognized in medical literature as an effective osmotic laxative for bowel preparation, particularly as a second-line option when other preparations like sodium picosulfate/magnesium citrate prove inadequate. Macrogol 3350 works by drawing water into the intestines, softening stool and increasing bowel movements to thoroughly cleanse the colon before diagnostic procedures. Pharmacologically classified as an osmotic laxative, it causes minimal fluid and electrolyte disturbances because the added electrolytes help maintain the body's balance during the cleansing process.

  • Sodium picosulfate/magnesium citrate

    This medication is taken orally as a powder that needs to be dissolved in water before consumption for bowel cleansing prior to colonoscopy. It is established in medical practice as a first-line bowel preparation agent due to its generally good tolerability profile and effectiveness. The medication works through a dual mechanism: sodium picosulfate stimulates the intestinal wall to increase peristalsis (bowel contractions), while magnesium citrate draws water into the bowel to soften stool and enhance evacuation. Pharmacologically, it is classified as a stimulant and osmotic laxative combination that effectively cleanses the colon with relatively small volumes of fluid intake compared to some other preparation methods.

Investigated diseases

Inadequate bowel preparation – Inadequate bowel preparation refers to insufficient clearing of fecal material from the colon prior to colonoscopy. It occurs when the bowel cleansing process fails to provide adequate visualization of the colonic mucosa during the procedure. This condition can be characterized by the presence of solid or semi-solid stool, cloudy liquid, or adherent material in the colon. The Boston Bowel Preparation Scale (BBPS) is commonly used to assess preparation quality, with scores below 6 indicating inadequate preparation. Poor preparation can obscure visualization of polyps and other lesions, potentially leading to missed diagnoses during colonoscopy.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-520818-65-00Protocol codePICO-TRATEstimated enrolment188 patientsSponsorUni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.

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