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

Recruiting Phase 3 Interventional Study
Crohn Disease
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial. Healthy Volunteers Welcome You do not need to have the condition being studied to take part.
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At a Glance
Age
18 – 74
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
150 (estimated)
Sponsor
Assistance Publique - Hôpitaux de Paris · Other
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About This Trial

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.

Trial Locations
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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 s…
Contacts

Harry SOKOL, PU-PH

01 49 28 31 62

harry.sokol@aphp.fr

CONTACT

Laurent BEAUGERIE, PU-PH

laurent.beaugerie@aphp.fr

laurent.beaugerie@aphp.fr

CONTACT