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Study on Preventing Recurrent Pouchitis in Ulcerative Colitis Patients Using Fecal Microbiota Transplant and Sodium Chloride

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What is this trial about?

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

This clinical trial is focused on studying a condition known as recurrent pouchitis, which can occur in patients who have undergone a surgical procedure called ileal pouch-anal anastomosis for ulcerative colitis. The study aims to explore the effectiveness of a treatment involving fecal microbiota transplantation (FMT) using fresh donor feces, which is a suspension administered through an endoscopic procedure. This treatment is being compared to a placebo to determine if it can help delay the recurrence of pouchitis.

Participants in the study will receive either the fecal microbiota transplant or a placebo. The study will monitor the time it takes for pouchitis to return after the treatment. The trial will also observe any side effects and changes in the composition of gut bacteria over time. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who receives the actual treatment or the placebo, ensuring unbiased results.

The goal of this research is to find out if fecal microbiota transplantation can effectively prevent the recurrence of pouchitis in patients with a history of this condition following surgery for ulcerative colitis. The study will follow participants for a period to assess the long-term effects and benefits of the treatment.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying that the patient is 18 years or older, has undergone ileal pouch anal anastomosis (IPAA) surgery at least six months prior, and has experienced recurrent pouchitis.

    A Pouchitis Disease Activity Index (PDAI) score of less than 7 is required at screening to ensure remission status.

  2. Step 2

    Fecal microbiota transplantation

    The patient receives a fecal microbiota transplant using fresh donor feces administered endoscopically. This procedure is intended to delay the recurrence of pouchitis.

    A sham transplantation may be performed as part of the study's control measures.

  3. Step 3

    Monitoring and follow-up

    The patient is monitored for any clinical and endoscopic signs of relapse. The primary endpoint is the time between transplantation and relapse, defined by a PDAI score of 7 or higher.

    Secondary endpoints include relapse at weeks 24 and 52, the need for additional treatments, and the occurrence of any adverse events over a 104-week period.

  4. Step 4

    Microbiota analysis

    At 8 weeks post-transplantation, fecal samples are analyzed to assess microbiota engraftment. This involves comparing the microbiota composition before and after the transplant using advanced sequencing technology.

  5. Step 5

    Final evaluation

    The study concludes with a final evaluation of the patient's condition, including the assessment of any disability related to inflammatory bowel disease (IBD) at various intervals throughout the study.

Who can join the trial?

8 criteria

  • Must be a male or female who is at least 18 years old at the time of signing the informed consent form.
  • Must understand and voluntarily sign an informed consent form before any study-related assessments or procedures.
  • Must be willing and able to follow the study visit schedule and other study requirements.
  • Must have had surgery called ileal pouch anal anastomosis (IPAA) at least 6 months before the screening visit. This is a type of surgery for ulcerative colitis.
  • Must have a diagnosis of recurrent pouchitis, which means having at least 2 episodes in the last year or relapsing right after responding to antibiotic treatment. Antifungal medication is allowed until the day before transplantation.
  • Must be in remission, meaning the condition is under control, with a Pouchitis Disease Activity Index (PDAI) score of less than 7 at the screening. This index measures the severity of pouchitis.
  • Must be affiliated with a social security system or be a beneficiary of such a system.
  • If female and able to have children, must have a negative pregnancy test at screening and agree to use effective birth control methods.

Who cannot join the trial?

4 criteria

  • Patients who have not had surgery called IPAA (Ileal Pouch-Anal Anastomosis) for a condition known as ulcerative colitis.
  • Patients who do not have a condition called recurrent pouchitis, which is inflammation of the pouch created during the IPAA surgery.
  • Patients who are not within the specified age range for the study.
  • Patients who belong to a vulnerable population, which means they might need special protection or care.
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Investigated drugs

Fecal Microbiota Transplantation (FMT) is a procedure where stool from a healthy donor is processed and then introduced into the intestinal tract of a patient. The goal is to restore a healthy balance of bacteria in the gut. In this trial, FMT is being studied to see if it can help prevent the recurrence of pouchitis, which is an inflammation of the pouch created during surgery for ulcerative colitis.

What is already known about the treatment

Fecal Microbiota Transplantation – This treatment involves the transfer of stool from a healthy donor into the gastrointestinal tract of a patient. It is currently being studied in clinical trials for its effectiveness in preventing recurrent pouchitis in patients with ulcerative colitis who have undergone ileo-anal anastomosis surgery. The main therapeutic indication is to delay the relapse of pouchitis, a condition characterized by inflammation of the ileal pouch. The mechanism of action is believed to involve the restoration of a healthy balance of gut bacteria, which can help reduce inflammation and improve gut health. Fecal microbiota transplantation is classified under biological therapies, focusing on altering the gut microbiome to achieve therapeutic effects.

Investigated diseases

  • Ulcerative Colitis

    Ulcerative colitis is a chronic inflammatory condition affecting the colon and rectum. It is characterized by continuous inflammation of the innermost lining of the large intestine, leading to symptoms such as abdominal pain, diarrhea, and rectal bleeding. Over time, the inflammation can cause ulcers to form on the colon's lining. The disease often progresses with periods of exacerbation and remission. Complications can include severe bleeding, perforation of the colon, and increased risk of colon cancer. The exact cause is unknown, but it is believed to involve an immune system malfunction.

  • Pouchitis

    Pouchitis is an inflammation of the ileal pouch, which is created during surgery for ulcerative colitis or familial adenomatous polyposis. This condition typically occurs in patients who have undergone ileal pouch-anal anastomosis (IPAA) surgery. Symptoms include increased stool frequency, abdominal pain, and sometimes fever. The inflammation can lead to discomfort and affect the function of the pouch. Pouchitis can be acute or chronic, with some patients experiencing recurrent episodes. The exact cause is not well understood, but it may involve bacterial imbalance or immune response.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-517078-52-00Protocol codeRC17_0021Estimated enrolment42 patientsSponsorCentre Hospitalier Universitaire De Nantes

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