Impact of Fecal Microbiota Transplantation in Ulcerative Colitis: a Randomized, Sham Controlled Trial
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.
• 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)
• 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