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Study on Fecal Microbiota Transplantation for Crohn's Disease Patients in Remission After Stopping Anti-TNF Therapy

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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 Crohn's disease, a condition that causes inflammation in the digestive tract, leading to symptoms like abdominal pain and diarrhea. The study is exploring the use of fecal microbiota transplantation (FMT) as a treatment option. FMT involves transferring stool from a healthy donor into the gastrointestinal tract of a patient to help restore a healthy balance of bacteria. The trial will compare the effects of FMT with a placebo treatment, which is a substance with no active therapeutic effect.

The purpose of the study is to evaluate the effectiveness of FMT as a maintenance treatment for patients with Crohn's disease who have been in remission without the use of steroids for at least six months. These patients have previously been treated with anti-TNF agents, which are medications that help reduce inflammation. The study will monitor participants over a period of 52 weeks to see if FMT can help maintain remission after stopping anti-TNF treatment.

Participants in the study will receive either the FMT treatment or a placebo. The FMT can be administered in different forms, such as an oral capsule or an enema, which is a liquid introduced into the rectum. The study will track the participants' health and symptoms throughout the year to determine the success of the treatment. The goal is to see if FMT can help keep Crohn's disease in remission without the need for additional medication.

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 visit and consent

    Upon joining the study, the first step involves an initial visit where eligibility is confirmed. This includes verifying age, diagnosis of Crohn's disease, and ensuring the patient has been in steroid-free remission for at least six months.

    During this visit, informed written consent is obtained, confirming understanding and agreement to participate in the trial.

  2. Step 2

    Baseline assessment

    A comprehensive assessment is conducted to establish a baseline. This includes measuring the Crohn's Disease Activity Index (CDAI) to ensure it is below 150, indicating remission.

    Additional tests may include blood tests, stool samples, and other evaluations to assess overall health and disease status.

  3. Step 3

    Treatment initiation

    The treatment phase begins with the administration of either a fecal microbiota transplant (FMT) or a placebo. The method of administration can be oral or rectal, depending on the group assignment.

    For oral administration, a double encapsulated oral transplant of fecal microbiota or placebo is used. For rectal administration, an enema transplant of fecal microbiota or placebo is provided.

  4. Step 4

    Follow-up visits

    Regular follow-up visits are scheduled at weeks 6, 12, 24, 36, 48, and 52. These visits involve monitoring health status, assessing disease activity, and collecting samples for analysis.

    During these visits, blood tests, stool samples, and other assessments are conducted to measure inflammation and microbiota composition.

  5. Step 5

    Final assessment

    At week 52, a final assessment is conducted to evaluate the effectiveness of the treatment. This includes measuring the CDAI to confirm clinical remission and conducting an endoscopic examination to assess the intestinal lining.

    The goal is to determine if the treatment has maintained remission without any disease flare-ups throughout the trial period.

Who can join the trial?

9 criteria

  • Age between 18 and 74 years old.
  • Diagnosed with Crohn's disease for at least 6 months. Crohn's disease is a condition that causes inflammation in the digestive tract.
  • Currently in steroid-free clinical remission for at least 6 months while using an anti-TNF agent. This means the patient has no symptoms without using steroids and has been stable on a specific medication that reduces inflammation.
  • No recent flare-ups or changes in Crohn's disease treatment in the last 6 months.
  • Willing to stop using the anti-TNF treatment.
  • If female and able to have children, must use effective birth control during the treatment period.
  • Must have health insurance.
  • Must provide written consent to participate in the study.
  • For healthy volunteer donors: Must have regular bowel movements, defined as at least one stool every other day and no more than two stools per day.

Who cannot join the trial?

3 criteria

  • Patients who are not in steroid-free clinical remission for at least 6 months. (This means you must not have needed steroids to control your Crohn's disease for at least 6 months.)
  • Patients who have not been using an anti-TNF agent and are now stopping it. (Anti-TNF agents are medications used to reduce inflammation in conditions like Crohn's disease.)
  • Patients who are part of a vulnerable population. (This generally refers to groups who may need special protection, such as children, pregnant women, or those unable to give consent.)
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Investigated drugs

  • Fecal Microbiota Transplantation (FMT)

    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 the balance of bacteria in the gut, which can be disrupted in conditions like Crohn's disease. By introducing healthy bacteria, FMT aims to improve gut health and reduce symptoms associated with Crohn's disease.

  • Anti-TNF Agents

    are medications used to reduce inflammation in the body. They work by blocking a protein called tumor necrosis factor (TNF), which is involved in causing inflammation. In the context of Crohn's disease, anti-TNF agents help to control symptoms and maintain remission. In this trial, the focus is on patients who have been in remission without the need for steroids for at least six months while using anti-TNF agents. The study aims to evaluate the effectiveness of FMT as a maintenance treatment after stopping anti-TNF therapy.

What is already known about the treatment

Fecal Microbiota Transplantation (FMT) – Fecal Microbiota Transplantation is administered through a procedure where processed stool from a healthy donor is introduced into the gastrointestinal tract of a patient. This treatment is currently being studied in clinical trials for its effectiveness in maintaining remission in Crohn's disease patients who have stopped using anti-TNF medications. The main therapeutic indication for FMT in this context is to help maintain a symptom-free state in Crohn's disease without the use of steroids. At the molecular level, FMT works by restoring a healthy balance of gut bacteria, which can help reduce inflammation and improve gut health. It is classified under microbiome-based therapies, focusing on altering the gut flora to achieve therapeutic effects.

Investigated diseases

Crohn's disease – Crohn's disease is a chronic inflammatory condition of the gastrointestinal tract, primarily affecting the small intestine and colon. It is characterized by periods of active disease, known as flares, and periods of remission. During a flare, symptoms such as abdominal pain, diarrhea, and fatigue are common. The inflammation can lead to complications like strictures, fistulas, and malnutrition. The disease can affect any part of the gastrointestinal tract from the mouth to the anus, and the inflammation can penetrate through the entire thickness of the bowel wall. The exact cause of Crohn's disease is unknown, but it involves an abnormal immune response to intestinal bacteria in genetically susceptible individuals.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-511822-30-00Protocol codeAPHP 190183Estimated enrolment350 patientsSponsorAssistance Publique Hopitaux De Paris

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