Phase 3 Crohn's Disease and Colitis Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
For patients:
- Adults aged 18 to 74 years old
- People who have been diagnosed with Crohn's disease (using a specific set of medical guidelines called the Lennard-Jones criteria) for at least 6 months
- People whose Crohn's disease has been in remission (no active symptoms) for at least 6 months without using steroids, while on an anti-TNF medication, and who are willing to stop that anti-TNF treatment
- Women of childbearing age who are using an active form of contraception throughout the treatment period (up to week 52 of the trial)
- People who have health insurance coverage
- People who have read, understood, and signed a written consent form agreeing to take part
For healthy volunteer donors:
- Adults aged 18 to 49 years old
- People with a body mass index (a measure of body weight relative to height) between 17 and 30
- People who have regular bowel movements, meaning at least one bowel movement every two days but no more than two per day
- People who have health insurance coverage
- People who have read, understood, and signed a written consent form agreeing to take part
Who may not be able to join:
For patients:
- People whose Crohn's disease has led to complications that require surgery
- People for whom a colonoscopy (a camera examination of the bowel) or anaesthesia is not medically safe
- People who are pregnant or breastfeeding during the study
- People whose Crohn's disease only affects the upper digestive tract (such as the oesophagus, stomach, or upper small intestine)
- People who currently have active disease around the anal or perineal area, such as an abscess, an open draining fistula, a surgical drain (seton), or an ulcer in that area
- People who have had more than one surgery to remove part of the small bowel, or who have had more than one metre of small bowel removed
- People who currently have or recently had a stoma (a surgically created opening in the abdomen for waste), or who have had any abdominal surgery in the 3 months before joining the trial
- People currently taking part in another interventional research study
- People who are under legal protection or guardianship
For healthy volunteer donors:
- Full details are listed in the trial protocol — the trial site should be contacted directly for this information
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Harry SOKOL, PU-PH, Assistance Publique - Hôpitaux de Paris
Phone: 01 49 28 31 62
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
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
Can't join this trial?
Data last synced from ClinicalTrials.gov: 22 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.