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Study of Fecal Microbiota Transplantation in Capsule Form Compared to Placebo for Patients with Severe Irritable Bowel Syndrome

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What is this trial about?

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

This clinical trial focuses on treating severe Irritable Bowel Syndrome (IBS), a condition that affects the digestive system causing symptoms like abdominal pain, bloating, and changes in bowel habits. The study tests a treatment called Fecal Microbiota Transplantation (FMT), which involves transferring beneficial gut bacteria from healthy donors to patients. The treatment is given in the form of oral capsules containing frozen fecal microbiota.

The purpose of this research is to determine if these oral capsules containing fecal microbiota are effective in reducing the severity of IBS symptoms compared to placebo. The treatment involves taking oral capsules that contain either the fecal microbiota transplant or placebo. The maximum daily dose is 32 grams, and the treatment period lasts for one day.

The study will monitor patients for 24 weeks to assess changes in their IBS symptoms and overall quality of life. The research team will evaluate how the treatment affects the balance of bacteria in the digestive system and track any improvements in IBS-related symptoms. This is a double-blind study, which means neither the patients nor the doctors know who receives the actual treatment or placebo during the study period.

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

    Initial assessment

    Your participation begins with an evaluation of Irritable Bowel Syndrome (IBS) severity using a special scoring system called IBS-SSS.

    The medical team will confirm that your IBS severity score is above 300 points, which indicates severe symptoms.

  2. Step 2

    Treatment assignment

    You will be randomly assigned to receive either:

    - Fecal microbiota transplant capsules: containing processed gut bacteria from healthy donors

    - Placebo capsules: identical-looking capsules without active ingredients

    Neither you nor your doctor will know which type of capsules you receive.

  3. Step 3

    Capsule administration

    You will take the assigned capsules by mouth.

    The capsules are double-encapsulated, meaning they have two protective layers.

    The medical team will provide specific instructions about when and how to take the capsules.

  4. Step 4

    12-week assessment

    After 12 weeks, you will undergo an evaluation to measure changes in your IBS symptoms.

    A stool sample will be collected to analyze the composition of gut bacteria.

    You will complete questionnaires about your symptoms and quality of life.

  5. Step 5

    24-week follow-up

    A final assessment will occur at 24 weeks after taking the capsules.

    This includes another evaluation of your IBS symptoms and collection of a stool sample.

    You will complete final questionnaires about your symptoms and quality of life.

  6. Step 6

    Safety monitoring

    Throughout the study period, any health changes or unusual symptoms should be reported.

    Regular safety assessments will be conducted to monitor your health status.

Who can join the trial?

7 criteria

  • Must be between 18 and 75 years old
  • Must have been diagnosed with Irritable Bowel Syndrome (IBS) according to Rome IV criteria, including any of these types: - IBS with constipation (IBS-C) - IBS with diarrhea (IBS-D) - IBS with mixed bowel habits (IBS-M)
  • Must have severe symptoms with an IBS Severity Scoring System (IBS-SSS) score greater than 300
  • Must have tried at least two previous treatments that did not work effectively
  • Must have valid health insurance (AME not accepted)
  • Must be able and willing to provide written informed consent
  • Women who can become pregnant must use effective birth control throughout the entire study duration

Who cannot join the trial?

16 criteria

  • Age below 18 or above 65 years
  • Current pregnancy or breastfeeding
  • History of inflammatory bowel disease (IBD) such as Crohn's disease or ulcerative colitis
  • Previous abdominal surgery in the last 3 months
  • Current use of antibiotics or having used them in the past 3 months
  • Active infections or fever
  • History of severe allergic reactions
  • Current participation in other clinical trials
  • Inability to swallow oral capsules
  • Severe mental health conditions that could affect participation
  • History of drug or alcohol abuse in the past 12 months
  • Severe immune system disorders
  • Uncontrolled diabetes or thyroid disease
  • Severe liver or kidney disease
  • Use of medications that could interfere with the study treatment
  • Known allergies to any components of the study medication
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Investigated drugs

Fecal Microbiota Transplantation (FMT) is a medical treatment that involves transferring processed stool from healthy donors to patients. In this trial, it is delivered in the form of oral capsules containing frozen material. This therapy aims to restore healthy gut bacteria in patients with severe irritable bowel syndrome. The treatment works by introducing beneficial microorganisms into the patient's digestive system, which may help improve gut function and reduce symptoms of IBS.

What is already known about the treatment

Fecal Microbiota Transplant (FMT) Capsules - An innovative oral treatment form containing processed and frozen fecal microbiota, administered as capsules for patients with severe Irritable Bowel Syndrome (IBS). This therapy works by introducing beneficial gut bacteria from healthy donors to restore the patient's intestinal microbiome balance, potentially improving digestive function and reducing IBS symptoms. The treatment is currently being investigated in clinical trials as an alternative approach for patients who haven't responded well to conventional IBS treatments, representing a new frontier in gastrointestinal medicine that leverages the growing understanding of gut microbiota's role in digestive health.

Investigated diseases

Irritable Bowel Syndrome (IBS) - A chronic functional disorder affecting the digestive system that causes recurring abdominal pain and changes in bowel movements. The condition involves irregular patterns of bowel movements, where a person may experience diarrhea, constipation, or both alternately. IBS can cause bloating, excessive gas, and abdominal discomfort that may be relieved after bowel movements. The severity of symptoms can vary from mild to severe, with some people experiencing periods of symptom flare-ups and remissions. The condition affects the function of the bowel but does not cause permanent damage to the digestive system.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516099-13-00Protocol codeAPHP180583Estimated enrolment150 patientsSponsorAssistance Publique Hopitaux De Paris

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