Fecal Microbiota Transplantation (FMT): The colonoscopy for FMT will be planned as soon as possible and never more than 5 weeks after inclusion visit.
After colon cleansing using Polyethylen 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 physio, see donor section for details) or sham transplantation (FMT vehicle) in the cecum.
Sham-transplantation Placebo: The sham-transplantation will be planned as soon as possible and never more than 5 weeks after inclusion visit.
After colon cleansing using Polyethylen glycol, the patient will have a colonoscopy under general anesthesia.
The patient will then sham transplantation (FMT vehicle) in the cecum.
Study summary
Ulcerative colitis (UC) is a chronic relapsing inflammatory bowel disease. UC pathogenesis remains poorly understood but involves an inappropriate immune response toward an unbalanced gut microbiota (called dysbiosis) in predisposed hosts.
The purpose of this study is to determine the effect of the fecal microbiota transplantation on UC.
Eligibility
Sex
ALL
Min age
18 Years
Max age
74 Years
Healthy volunteers
Accepted
Inclusion Criteria:
Inclusion Criteria for patients :
* Age ≥ 18 years and \< 75 years
* Ulcerative colitis (according to the Lennard Jones criteria) diagnosed for at least 3 months and :
* Currently active (PMC \> 1) and planned to be treated by systemic corticosteroids (minimum 40mg prednisone equivalent daily) Or
* Currently treated by systemic corticosteroid (minimum 40 mg prednisone equivalent daily) within max 3 weeks Or
* Steroid dependent patients (at least one unsuccessful attempt to discontinue steroid within the last 6 months before inclusion)
* Patient with health insurance (AME excepted)
* Informed written consent
* Female of child-bearing age with an active contraception and this during at least period of treatment until the end of active follow-up period (week 24)
Inclusion Criteria for healthy volunteers donors :
* 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:
Exclusion Criteria for patients :
* UC complication requiring surgical treatment
* Patient treated with high dose corticosteroid more than three weeks before inclusion (≥ 40 mg prednisone equivalent daily) except in case of steroid-dependence
* Contraindication to colonoscopy or anesthesia
* Pregnancy or breastfeeding during the study
* Treatment preceding the colonoscopy with:
* intravenous infliximab and/or vedolizumab and/or ustekinumab (\< 6 weeks before the planned date of the colonoscopy) and/or subcutaneous infliximab (\<2 weeks before the planned date of the colonoscopy), and /or adalimumab (\<2 weeks before the planned date of the colonoscopy) and/or golimumab and/or tofacitinib (\<4 weeks before the planned date of the colonoscopy)
* immunosuppressant (thiopurine, methotrexate, tacrolimus or other classical immunosuppressant) started or stopped \< 3 months before the planned date of the colonoscopy
* Antibiotics, antifungic or probiotics treatment \< 4 weeks before the planned date of the colonoscopy
* participation in any other interventional study
* patient under legal protection
Exclusion Criteria for healthy volunteers donors :
\- For details, please see protocol.
Primary outcome measure(s)
Steroid-free clinical and endoscopic remission — 12 weeks after FMT or sham-transplantation Steroid-free clinical and endoscopic remission defined as a total Mayo score of 2 or lower and no subscore higher than 1 and mucosal healing defined as an endoscopic subscore of 0 or 1 (Sigmoidoscopy).
Trial sites (1)
Facility
City
Region
Status
Service de Gastroentérologie et Nutrition Hôpital Saint Antoine
Paris
Paris
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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