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Macrogol 3350

Clinical trials involving Macrogol 3350 are studying how bowel-cleansing and related treatment regimens perform in different patient groups. The trials look at effectiveness, tolerance, and safety in people preparing for colonoscopy, children with constipation, and other conditions.

Table of Contents

Trials overview

The trial data show that Macrogol 3350 appears in studies about bowel preparation, constipation-related care, and some other clinical research settings.[1][2][4]

Several studies use Macrogol 3350-based products as part of a plan to clean the bowel before tests such as colonoscopy or capsule endoscopy.[3][4][9][10][11]

Conditions and patient groups

The studies include different patient groups, not just one disease.[1][2][5][7]

  • People with recurrent urinary tract infections, meaning repeated urine infections, in a phase II study looking at fecal microbiota transfer and related preparation steps.[1]

  • Patients with axial spondyloarthritis, a type of inflammatory disease that affects the spine and nearby joints, in a phase II fecal microbiota transplantation trial.[2]

  • People having small bowel capsule endoscopy, a test where a small camera capsule looks at the small intestine, in a study of bowel cleansing quality.[3]

  • Patients needing bowel preparation before colonoscopy, an exam of the large bowel with a camera tube, in phase III comparison studies.[4][10]

  • Critically ill children with constipation, meaning difficult or infrequent bowel movements, in a phase III prevention study.[5]

  • Patients with fecal incontinence, meaning loss of bowel control, in a phase III motility study.[6]

  • Patients with advanced cancer who are starting opioids for pain, in a low-intervention study focused on constipation prevention.[7]

  • People with unresectable hepatocellular carcinoma, a liver cancer that cannot be removed by surgery, in a phase II study of fecal microbiota transfer added to cancer treatment.[8]

  • Patients with Crohn’s disease, a long-term inflammatory bowel disease, in a phase II imaging study.[9]

  • Children and teenagers with colonic disease, meaning disease of the large bowel, in a phase III cleansing study before colonoscopy.[11]

Trial phases and study designs

Most of the studies are interventional, which means the researchers assign a treatment or preparation and then measure the results.[1][2][4]

The source data include Phase 2 studies, Phase 3 studies, and one low-intervention study.[1][2][4][5][7]

  • Phase 2 studies are used to explore whether a strategy seems effective and to learn more about the outcome in a smaller group of patients.[1][2][8][9]

  • Phase 3 studies compare strategies in larger groups and look for stronger proof that one approach works better or is not worse than another.[4][5][6][10][11]

  • Low intervention means the study uses routine products or standard care and focuses on outcomes with less added study burden.[3][7]

Outcomes measured in the trials

The main outcomes differ by study, but most of them focus on how well the bowel is cleaned, how symptoms change, or whether the treatment helps the disease-related goal.[3][4][5][7]

  • New UTI episodes within 180 days after treatment are measured in the recurrent UTI study, using symptom and urine culture criteria.[1]

  • MSP variation and the proportion of patients meeting ASAS 20 improvement criteria are measured in the axial spondyloarthritis study; these are trial-specific ways to track change in disease activity.[2]

  • Small bowel cleansing quality is measured with an accepted cleansing scale in the capsule endoscopy study.[3]

  • Adequate bowel preparation is measured with the BBPS, using a total score of at least 6 and at least 2 points per bowel segment in the colonoscopy preparation study.[4]

  • Stool output is the main endpoint in the critically ill child constipation study.[5]

  • Time to onset of high amplitude propagative contractions, which are strong bowel muscle waves, is measured in the fecal incontinence study before and after botulinum toxin injections.[6]

  • Constipation is measured using the Bowel Function Index, with a score below 30 used as the study definition in advanced cancer.[7]

  • Disease control rate and adverse events of grade greater than 3 are measured in the hepatocellular carcinoma study, so the researchers can assess both benefit and safety.[8]

  • Homogenous contrast filling of the terminal ileum, meaning even filling of the last part of the small bowel, is the main outcome in the Crohn’s disease ultrasound study.[9]

  • Tolerability and efficacy are compared in the colonoscopy cleansing studies, including non-inferiority testing, which asks whether one treatment is not worse than the other by a set margin.[10][11]

Key study details

Some trials use Macrogol 3350 directly as part of the study intervention, while others list related bowel-cleansing products in the same research program.[4][5][7]

The enrollment sizes range from small studies with 15 or 21 participants to larger studies with 400 participants, which shows that the research includes both focused early testing and bigger comparison studies.[6][8][10]

  • The recurrent UTI study is a phase II trial with 24 planned participants and aims to study prevention of new infection episodes after treatment.[1]

  • The axial spondyloarthritis study is a phase II trial with 25 participants and looks at both microbiota correction and clinical improvement.[2]

  • The capsule endoscopy study is a low-intervention study with 156 participants and compares preparation protocols for better visualization of the small bowel.[3]

  • The colonoscopy preparation study in adults is a phase III trial with 188 participants and tests whether the Macrogol 3350 and electrolytes combination gives adequate bowel cleansing.[4]

  • The critically ill child study is a phase III trial with 233 participants and tests whether prophylactic treatment can prevent constipation.[5]

  • The fecal incontinence study is a phase III trial with 21 participants and measures changes in bowel motility after injections.[6]

  • The advanced cancer study is a low-intervention trial with 250 participants and compares constipation prevention strategies during opioid treatment.[7]

  • The hepatocellular carcinoma study is a phase II trial with 15 participants and evaluates safety plus disease control after fecal microbiota transfer added to cancer therapy.[8]

  • The Crohn’s disease study is a phase II trial with 104 participants and uses ultrasound to study the small bowel after ingestion of the study preparation.[9]

  • The colonoscopy comparison study in adults is a phase III trial with 400 participants and compares two bowel cleansing agents for efficacy and tolerability.[10]

  • The pediatric colon disease study is a phase III trial with 241 participants and measures bowel cleansing success in children and teenagers.[11]

What patients should know from these trials

From the trial data, Macrogol 3350 is being studied mainly as part of bowel cleansing plans and related bowel care research, rather than as a stand-alone topic.[3][4][5][10][11]

The research aims are practical: better bowel cleaning, better symptom control, and clearer understanding of which preparation works best for which patient group.[1][2][7][8]

Because the studies involve different conditions and different ages, the exact participation rules and study goals depend on the specific trial.[1][5][11]

Trial IDPhaseCondition studiedStatusEnrollment
2025-520452-28-00Phase 2Recurrent urinary tract infectionsAuthorised24
NCT05654753Phase 2Axial spondyloarthritisAuthorised25
2025-520671-38-00Low InterventionSmall bowel capsule endoscopy preparationAuthorised156
2025-520818-65-00Phase 3Second line treatment for colonoscopy preparationAuthorised188
2023-509718-12-01Phase 3Constipation in critically ill childrenAuthorised233
NCT05998187Phase 3Fecal incontinenceAuthorised21
2023-509462-38-00Low InterventionPrevention of opioid-induced constipation in advanced cancerAuthorised250
2023-510504-45-00Phase 2Unresectable hepatocellular carcinomaAuthorised15
2023-508500-38-00Phase 2Crohn’s diseaseAuthorised104
2024-518544-21-00Phase 3Colonoscopy bowel cleansing comparisonAuthorised400
2025-522046-42-00Phase 3Colonic disease in children and teenagersAuthorised241

FAQ

  • What are clinical trials with Macrogol 3350 trying to find out? They are mainly checking how well Macrogol 3350-based regimens work in bowel preparation and related uses. The trials also measure how well patients tolerate the treatment and whether it improves study outcomes.
  • Who can take part in these trials? The target groups vary by trial. They include adults preparing for colonoscopy, children and teenagers, critically ill children with constipation, and patients with conditions such as advanced cancer, Crohn's disease, axial spondyloarthritis, or recurrent urinary tract infections.
  • What trial phases are listed for Macrogol 3350 studies? Most trials are Phase 2 or Phase 3 studies. One study is listed as low intervention, which means it uses routine care or standard products and focuses on observing outcomes.
  • What outcomes are the trials measuring? Common outcomes include bowel cleansing quality, stool output, constipation scores, symptom improvement, and disease control. Some trials also measure microbiota changes, which means changes in the gut bacteria.
  • Are all these trials studying the same condition? No. Some studies focus on colonoscopy preparation, while others study constipation, fecal microbiota transfer, or different diseases where Macrogol 3350 is part of the study plan. The exact goal depends on the trial.

Ongoing Clinical Trials on Macrogol 3350

  • Study on Improving Small Bowel Visualization in Capsule Endoscopy for Patients Using Ascorbic Acid, Sodium Ascorbate, Potassium Chloride, and Simeticone

    Not yet recruiting

    3 1 1 1
    Investigated drugs:
    Spain

Glossary

  • Clinical trial: A research study in people that tests whether a treatment or strategy works and is safe.
  • Phase 2: An early trial stage that looks mainly at whether a treatment seems to work and how well it is tolerated.
  • Phase 3: A later trial stage that compares treatments in larger groups of patients to confirm benefit and safety.
  • Low intervention: A study that uses routine or standard medical products and adds little extra risk beyond usual care.
  • Enrollment: The number of people planned to join the study.
  • Primary outcome: The main result the researchers want to measure.
  • Bowel preparation: Cleaning the bowel before tests like colonoscopy so the doctor can see the lining more clearly.
  • Colonoscopy: An examination of the large bowel using a flexible tube with a camera.
  • BBPS: Boston Bowel Preparation Scale, a scoring system used to judge how clean the bowel is before colonoscopy.
  • Microbiota: The community of tiny organisms, mainly bacteria, that live in the gut.
  • Disease control rate: The percentage of patients whose disease does not get worse, and may improve or stay stable.
  • Constipation: Having difficult, infrequent, or hard bowel movements.

References

  1. https://clinicaltrials.gov/study/2025-520452-28-00
  2. https://clinicaltrials.eu/trial/study-on-fecal-microbiota-transplantation-for-patients-with-axial-spondyloarthritis-resistant-to-conventional-treatment/
  3. https://clinicaltrials.gov/study/2025-520671-38-00
  4. https://clinicaltrials.gov/study/2025-520818-65-00
  5. https://clinicaltrials.gov/study/2023-509718-12-01
  6. https://clinicaltrials.eu/trial/study-on-the-effects-of-botulinum-toxin-type-a-and-a-drug-combination-on-rectal-function-in-patients-with-fecal-incontinence/
  7. https://clinicaltrials.gov/study/2023-509462-38-00
  8. https://clinicaltrials.gov/study/2023-510504-45-00
  9. https://clinicaltrials.gov/study/2023-508500-38-00
  10. https://clinicaltrials.gov/study/2024-518544-21-00
  11. https://clinicaltrials.gov/study/2025-522046-42-00