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Impact of Fecal Microbiota Transplantation in Ulcerative Colitis
Sponsor: Assistance Publique - Hôpitaux de Paris
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.
Official title: Impact of Fecal Microbiota Transplantation in Ulcerative Colitis: a Randomized, Sham Controlled Trial
Key Details
Gender
All
Age Range
18 Years - 74 Years
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2018-09-17
Completion Date
2027-03-27
Last Updated
2026-01-15
Healthy Volunteers
Yes
Conditions
Interventions
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.
Locations (1)
Service de Gastroentérologie et Nutrition Hôpital Saint Antoine
Paris, Paris, France