A Phase 3 interventional study of Fecal Microbiota Transplantation (FMT) and Sham-transplantation (placebo) in Crohn Disease, sponsored by Assistance Publique - Hôpitaux de Paris. Recruiting at 1 site in France. Open to participants aged 18 Years to 74 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-11.
Sponsored by Assistance Publique - Hôpitaux de Paris · Phase 3, Interventional, and Treatment
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.
Crohn's disease (CD) is a chronic inflammatory bowel disease affecting approximately 120000 patients in France, mostly at young age, and altering their quality of life.
Immunosuppressive treatments in CD are expensive and associated with potentially severe complications.
Alternative treatment strategies are thus required. This is particularly the case for CD patients in remission under anti-TNF agents for which no specific recommendation are available.
CD pathogenesis remains poorly understood but involves an inappropriate immune response toward an unbalanced gut microbiota in predisposed hosts.
Fecal microbiota transplantation (FMT) is currently recommended for treating recurrent Clostridium difficile infection. Although the pathogenesis involved in CD differs, FMT is a potential therapeutic strategy that could restore the appropriate host-microbiota crosstalk by transferring a healthy microbiota in a CD patient. However, as the gut microbiota is dramatically altered by intestinal inflammation, transferring a massive amount of microbes in an inflamed gut with epithelial barrier disruption might be a suboptimal strategy and could even have detrimental effects by allowing bacterial translocation.
Results of randomized controlled trial (RCT) in CD are lacking to date. We performed a pilot RCT (NCT02097797), evaluating the impact of a single FMT in 18 CD patients who achieved remission by corticosteroid treatment. A higher rate of steroid free clinical remission was observed in the FMT arm at 24 weeks (57.1% vs 33.3% in FMT and control arm respectively). CD Endoscopic Index of Severity was also improved at 6 weeks in FMT (median 8.5 vs 3.5 p=0.03) but not in sham group (median 2.4 vs 2.7 p=0.8). Moreover, the only 2 patients who early relapsed in the FMT group were those who did not show any engraftment of donor microbiota at week 6. These promising data, currently submitted for publication, suggest that using FMT as a maintenance treatment in CD can be effective. However, these promising findings need to be confirmed by a Phase III RCT.
1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.
This study's planned enrollment of 150 is above the median of 66 across 1,188 interventional studies indexed under Crohn Disease.
Browse Crohn Disease studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.
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Inclusion Criteria for patients :
Inclusion Criteria for healthy volunteer donor :
Exclusion Criteria for patients :
Exclusion Criteria for healthy volunteer donor :
- For details, please see protocol
Patients receiving the fecal microbiota transplantation (FMT) in 3 times after inclusion and randomisation (endoscopic and oral)
Drug: Fecal Microbiota Transplantation (FMT)
Patients receiving the sham-transplantation in 3 times after inclusion and randomisation (endoscopic and oral)
Drug: Sham-transplantation (placebo)
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).
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).
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
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
Time frame: 52 weeks after FMT or sham-transplantation
Relapse free survival
Relapse free survival rate from week 0 (V2) to week 52 (V8)
Time frame: 52 weeks after FMT or sham-transplantation
Mucosal healing
Proportion of endoscopic remission (SES-CD ≤2) at week 52 (V8) and change (in %) in endoscopic score (SES-CD) between week 0 (V2) and 52 (V8)
Time frame: 52 weeks after FMT or sham-transplantation
Clinical remission
Clinical remission defined by a CDAI \< 150 at week 52
Time frame: 52 weeks after FMT or sham-transplantation
Endoscopic remission
Endoscopic remission defined by a SES-CD ≤ 2 at week 52
Time frame: 52 weeks after FMT or sham-transplantation
Changes in inflammation 1
Measures of inflammation: blood cell count
Time frame: 6, 12, 24, 36, 48 and 52 weeks after TMF or sham-transplantation
Changes in inflammation 2
Measures of inflammation: C reactive protein (CRP) level
Time frame: 6, 12, 24, 36, 48 and 52 weeks after TMF or sham-transplantation
Changes in inflammation 3
Measures of inflammation: fecal calprotectin
Time frame: 6, 12, 24, 36, 48 and 52 weeks after TMF or sham-transplantation
Changes in intestinal microbiota composition
Microbiota composition and diversity using 16s sequencing technology
Time frame: 6, 12, 24, 36, 48 and 52 weeks after TMF or sham-transplantation
Plan to share: No
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