Actively Recruiting
Fecal Microbiota Transplantation in Crohn's Disease as Relay After Anti-TNF Withdrawal
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-08-11
150
Participants Needed
1
Research Sites
408 weeks
Total Duration
On this page
Sponsors
A
Assistance Publique - Hôpitaux de Paris
Lead Sponsor
C
CRB-HUEP
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Fecal Microbiota Transplantation in Crohn's Disease as Relay After Anti-TNF Withdrawal
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older and younger than 75 years
- Diagnosed with Crohn's disease for at least 6 months
- In steroid-free clinical remission for at least 6 months while on anti-TNF treatment
- No flare or treatment changes in the 6 months before joining the study
- Crohn's Disease Activity Index (CDAI) less than 150 the week before inclusion
- Female participants of child-bearing age must use active contraception during the treatment period
- Participants must have health insurance
- Participants must provide informed written consent
You will not qualify if you...
- Crohn's Disease complications requiring surgery
- Unable to undergo colonoscopy or anesthesia
- Pregnant or breastfeeding during the study
- Crohn's disease limited to upper gastrointestinal tract (esophagus, stomach, duodenum, jejunum)
- Active perineal disease (such as abscess, fistula, seton, or ulceration)
- History of more than one small bowel resection or resection longer than 1 meter
- Current stoma or stoma within the last 6 months, or any intra-abdominal surgery within 3 months before inclusion
- Participation in another interventional study
- Under legal protection
- Healthy volunteer donors have additional exclusion criteria detailed in the protocol
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Gastroenterology Department of Saint Antoine Hospital
Paris, France, 75012
Actively Recruiting
Research Team
H
Harry SOKOL, PU-PH
CONTACT
L
Laurent BEAUGERIE, PU-PH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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