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Study on the Effects of Fecal Microbiota Transplantation in Adults with Ulcerative Colitis

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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 the effects of a treatment for ulcerative colitis, a condition that causes inflammation and sores in the digestive tract. The treatment being tested is called an enema transplant of fecal microbiota, which involves introducing healthy bacteria from donor stool into the patient's colon to help restore a balanced gut environment. This treatment is compared to a placebo, which looks like the treatment but does not contain active ingredients.

The purpose of the study is to compare the effectiveness of the fecal microbiota transplant to the placebo in achieving remission of ulcerative colitis without the use of steroids. Participants in the study will receive either the fecal microbiota transplant or the placebo through a rectal procedure. The study will monitor the participants over a period of 12 weeks to assess their response to the treatment.

Throughout the study, researchers will evaluate the participants' health by looking at various factors, including the healing of the colon lining and changes in the gut bacteria. The study aims to determine if the fecal microbiota transplant can help patients maintain remission from ulcerative colitis without relying on steroids, which are commonly used to manage the condition. Participants will be closely monitored for any side effects or changes in their condition 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

    Joining the trial

    Upon joining the trial, you will be informed about the study's purpose and procedures. You will be required to provide informed written consent, confirming your understanding and willingness to participate.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm your eligibility. This includes verifying your age, diagnosis of ulcerative colitis for at least 3 months, and current treatment with systemic corticosteroids.

  3. Step 3

    Treatment administration

    You will receive either an enema transplant of fecal microbiota or a placebo enema transplant. Both are administered rectally as a suspension. The specific schedule and frequency of administration will be explained to you by the study team.

  4. Step 4

    Monitoring and follow-up

    Throughout the trial, your health and response to the treatment will be closely monitored. This includes regular check-ups and assessments to evaluate your clinical and endoscopic remission at week 12.

    You will be asked to report any side effects or changes in your condition. Commonly monitored symptoms include abdominal pain, nausea, vomiting, fever, and changes in bowel habits.

  5. Step 5

    Final assessment

    At the end of the 12-week period, a final assessment will be conducted to determine the effectiveness of the treatment. This includes evaluating your Mayo score and checking for mucosal healing through a procedure called sigmoidoscopy.

  6. Step 6

    Extended follow-up

    An extended follow-up period will continue until week 24 to monitor long-term effects and ensure your well-being. During this time, additional assessments of microbiota composition and diversity may be conducted.

Who can join the trial?

7 criteria

  • Must be an adult aged 18 years or older and younger than 75 years.
  • Must have been diagnosed with ulcerative colitis for at least 3 months.
  • Ulcerative colitis must be active and planned to be treated with systemic corticosteroids (at least 40mg of prednisone or equivalent daily), or currently being treated with these steroids within the last 3 weeks.
  • If the patient is steroid-dependent, they must have had at least one unsuccessful attempt to stop using steroids in the last 6 months.
  • Females of child-bearing age must use active contraception during the treatment period and until the end of the follow-up period (week 24).
  • Must have health insurance (except AME).
  • Must provide written informed consent to participate in the study.

Who cannot join the trial?

5 criteria

  • Patients who have not been diagnosed with ulcerative colitis for at least 3 months cannot participate. Ulcerative colitis is a condition where the colon and rectum become inflamed.
  • Patients who have not achieved clinical remission using systemic corticosteroids are excluded. Clinical remission means that the symptoms of the disease are reduced or gone.
  • Patients who are not able to stop using systemic corticosteroids are excluded. Systemic corticosteroids are medications that reduce inflammation throughout the body.
  • Patients who are not between the ages of 18 and 65 are excluded.
  • Both male and female patients are eligible, but those who are part of a vulnerable population are not included. A vulnerable population refers to groups who may have limited ability to give informed consent or are at higher risk of harm.
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Investigated drugs

Fecal Microbiota Transplantation is a therapy that involves transferring stool from a healthy donor into the gastrointestinal tract of a patient. The goal of this treatment is to restore a healthy balance of bacteria in the gut. In this clinical trial, it is being tested to see if it can help patients with ulcerative colitis, a condition that causes inflammation and sores in the digestive tract, achieve remission without the need for steroids. The therapy aims to improve the gut environment, which may help reduce symptoms and inflammation associated with ulcerative colitis.

What is already known about the treatment

Fecal Microbiota Transplantation – This treatment involves transferring stool from a healthy donor into the gastrointestinal tract of a patient, typically through a colonoscopy or enema. It is currently being studied for its effectiveness in treating ulcerative colitis, a chronic inflammatory bowel disease. The main goal is to restore a healthy balance of bacteria in the gut, which may help reduce inflammation and symptoms. This method is still under investigation, and its use in medicine is primarily experimental, with ongoing research to better understand its benefits and risks.

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 colon, leading to the formation of ulcers. The disease typically begins in the rectum and may extend to involve the entire colon. Symptoms often include abdominal pain, diarrhea, and rectal bleeding. The inflammation can cause frequent and urgent bowel movements. Over time, the disease can lead to complications such as strictures or an increased risk of colon cancer.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2024-511863-27-01Protocol codeP160931JEstimated enrolment350 patientsSponsorAssistance Publique Hopitaux De Paris

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