150
Participants
Start Date
September 22, 2021
Primary Completion Date
May 22, 2027
Study Completion Date
July 22, 2029
Fecal Microbiota Transplantation (FMT)
"The colonoscopy for FMT will be planned between 7 and 14 days after the last adalimumab or sub-cutaneous infliximab administration and 6 weeks +/- 7 days after the last intravenous infliximab administration 14 and 28 days following the last sub-cutaneous golimumab administration. After colon cleansing using polyethylene 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 saline (NaCl 0.9%), (FMT vehicle in the terminal ileum or the colon.~At W12 and W24 after first colonoscopy, the patient receives treatment by capsule (15 capsules contain 0.8g of stools by visit)."
Sham-transplantation (placebo)
"The colonoscopy for sham-transplantation will be planned between 7 and 14 days after the last adalimumab or sub-cutaneous infliximab administration and 6 weeks +/- 7 days after the last intravenous infliximab administration, 14 and 28 days following the last sub-cutaneous golimumab administration. After colon cleansing using polyethylene glycol, the patient will have a colonoscopy under general anesthesia. The patient will then receive either sham transplantation (frozen preparation of NaCl 0.9% with 10% glycerol) in the terminal ileum or the colon.~At S12 and S24 after first colonoscopy, the patient receives treatment by capsule (15 capsules contain placebo)."
RECRUITING
Gastroenterology Department of Saint Antoine Hospital, Paris
CRB-HUEP
UNKNOWN
Institut National de la Santé Et de la Recherche Médicale, France
OTHER_GOV
Assistance Publique - Hôpitaux de Paris
OTHER