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Recruiting Phase 3 NCT04997733

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

Trial Parameters

Condition Crohn Disease
Sponsor Assistance Publique - Hôpitaux de Paris
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 150
Sex ALL
Min Age 18 Years
Max Age 74 Years
Start Date 2021-09-22
Completion 2027-05-22
Interventions
Fecal Microbiota Transplantation (FMT)Sham-transplantation (placebo)

Brief 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 Criteria

Inclusion Criteria for patients : * Age ≥ 18 years and \< 75 years * Crohn's disease (according to the Lennard-Jones criteria) for at least 6 months * Patient in steroid-free clinical remission for at least 6 months under anti-TNF agent (no clinical evidence of flare nor change in Crohn's disease specific treatment (anti-TNF, immunosuppressive, …) within 6 months before inclusion) and CDAI \<150 the week before inclusion) and willing to withdraw anti-TNF treatment * Female of child-bearing age with an active contraception and this during at least the period of treatment (week 52) * Patient with health insurance * Informed Written consent Inclusion Criteria for healthy volunteer donor : * Age ≥ 18 years and \< 50 years * 17 kg/m² \< body mass index \< 30 kg/m² * Regular bowel movement defined as at least 1 stool every other day and maximum 2 stools per day * Subject with health insurance (AME excepted) * Informed written consent Exclusion Criteria for patients : * Crohn's Disease compli

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