Informations générales (source: ClinicalTrials.gov)
Impact of Fecal Microbiota Transplantation in Ulcerative Colitis: a Randomized, Sham Controlled Trial
Interventional
Phase 3
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
septembre 2018
décembre 2027
14 septembre 2025
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP Assistance publique - Hôpitaux de Paris | 13/12/2025 07:50:42 | Contacter | |||
| AP-HP - Hôpital Beaujon | |||||
| AP-HP - Hôpital Bicêtre | |||||
| AP-HP - Hôpital Henri Mondor-Albert Chenevier | |||||
| AP-HP - Hôpital Lariboisiere-Fernand Widal | |||||
| AP-HP - Hôpital Saint Antoine | |||||
| AP-HP - Hôpital Saint Louis | |||||
Critères
Tous
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
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 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.