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

• Status: Recruiting
• Trial end date: 2026-01-22
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: CRB-HUEP; Institut National de la Santé Et de la Recherche Médicale, France

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 complication requiring surgical treatment

• Contraindication to colonoscopy or anesthesia

• Pregnancy or breastfeeding during the study (Cf. Addendum 4)

• Diagnosis of Crohn's disease restricted to the upper gastrointestinal tract (oesophagus, stomach, duodenum, jejunum) Patient with active perineal disease (defined as evidence of perineal abscess or active draining fistula or presence of seton or presence of perineal ulceration)

• History of bowel resection

• Current stoma (Ileostomy or a colostomy) or stoma in the last 6 months or any other intra-abdominal surgery within 3 months prior to inclusion

• Participation in any other interventional study

• Patient under legal protection

Exclusion Criteria for healthy volunteer donor :

• For details, please see protocol