Status:
RECRUITING
Impact of Fecal Microbiota Transplantation in Ulcerative Colitis
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
CRB-HUEP
Institut National de la Santé Et de la Recherche Médicale, France
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18-74 years
Phase:
PHASE3
Brief 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 (...
Detailed Description
Ulcerative colitis (UC) is a chronic relapsing inflammatory bowel disease affecting approximately 90 000 patients in France, mostly at young age, and altering their quality of life. Conventional Immu...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 17 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 24 2027
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT03483246
Start Date
September 17 2018
End Date
December 24 2027
Last Update
January 15 2025
Active Locations (1)
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1
Service de Gastroentérologie et Nutrition Hôpital Saint Antoine
Paris, Paris, France, 75012