Fecal 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).
Sham-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).
Study 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
Sex
ALL
Min age
18 Years
Max age
74 Years
Healthy volunteers
Accepted
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 more than one small bowel resection or small intestine resection \> 1 meter
* 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
Primary outcome measure(s)
Evaluate the clinical efficacy of FMT versus sham transplantation as a maintenance treatment following anti-TNF agent withdrawal in patients with Crohn's disease in steroid-free clinical remission for at least 6 months under anti-TNF agent — 52 weeks after FMT or sham-transplantation Clinical remission (defined by a Crohn's disease activity index (CDAI) \<150) at week 52 (V8) without any flare between week 0 (colonoscopy (V2)) and week 52 (V8). Flare is defined by a CDAI (Addendum 2) above 250 or between 150 points and 250 points with a 70-point increase from baseline over 2 consecutive weeks and the need
Trial sites (1)
Facility
City
Region
Status
Gastroenterology Department of Saint Antoine Hospital
Paris
France
Recruiting
More Assistance Publique - Hôpitaux de Paris trials in France
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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