RecruitingPhase 3NCT04997733

Fecal Microbiota Transplantation in Crohn's Disease as Relay After Anti-TNF Withdrawal

Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

150 participants

Start Date

Sep 22, 2021

Study Type

INTERVENTIONAL

Conditions

Crohn Disease

Summary

Crohn's disease (CD) is a chronic inflammatory bowel disease. CD pathogenesis remains poorly understood but involves an inappropriate immune response toward an unbalanced gut microbiota in predisposed hosts. The purpose of this study is to evaluate de clinical efficacy of the fecal microbiota transplantation (FMT) as a maintenance treatment following anti-TNF agent withdrawal in CD's patient.

Eligibility

Min Age: 18 YearsMax Age: 74 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether fecal microbiota transplantation (FMT) — transferring healthy gut bacteria from a donor — can help maintain remission in Crohn's disease patients who are stopping their anti-TNF medication (such as infliximab or adalimumab). **You may be eligible if...** - You are 18–74 years old with confirmed Crohn's disease for at least 6 months - Your Crohn's disease has been in remission for at least 6 months on an anti-TNF medication - You and your doctor have decided to stop anti-TNF treatment - You have health insurance - If of childbearing age, you are using active contraception **You may NOT be eligible if...** - Your Crohn's disease requires surgery - You have active perianal disease (abscesses, fistulas) or disease only in the upper digestive tract - You have had multiple bowel surgeries or more than 1 meter of small intestine removed - You are pregnant or breastfeeding - You have a current colostomy or ileostomy - You are participating in another interventional study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFecal Microbiota Transplantation (FMT)

The colonoscopy for FMT will be planned between 7 and 14 days after the last adalimumab or sub-cutaneous infliximab administration and 6 weeks +/- 7 days after the last intravenous infliximab administration 14 and 28 days following the last sub-cutaneous golimumab administration. After colon cleansing using polyethylene glycol, the patient will have a colonoscopy under general anesthesia. The patient will then receive either FMT (frozen preparation of 50g of stools in 300ml of saline (NaCl 0.9%), (FMT vehicle in the terminal ileum or the colon. At W12 and W24 after first colonoscopy, the patient receives treatment by capsule (15 capsules contain 0.8g of stools by visit).

DRUGSham-transplantation (placebo)

The colonoscopy for sham-transplantation will be planned between 7 and 14 days after the last adalimumab or sub-cutaneous infliximab administration and 6 weeks +/- 7 days after the last intravenous infliximab administration, 14 and 28 days following the last sub-cutaneous golimumab administration. After colon cleansing using polyethylene glycol, the patient will have a colonoscopy under general anesthesia. The patient will then receive either sham transplantation (frozen preparation of NaCl 0.9% with 10% glycerol) in the terminal ileum or the colon. At S12 and S24 after first colonoscopy, the patient receives treatment by capsule (15 capsules contain placebo).

Locations(1)

Gastroenterology Department of Saint Antoine Hospital

Paris, France

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NCT04997733

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