Category :
Clinical
Abstract :
Inflammation of the intestinal reservoir (pouchitis) in patients with ulcerative colitis (UC) involves a deregulated inflammatory response to intestinal bacteria. Modification of this microbiota by a faecal microbiota transplantation (FMT) could modulate this response and prevent a possible relapse.
Main objective :
Compare chronic pouchitis time to relapse after faecal transplantation versus fictive transplantation in patients with ileal pouch-anal anastomosis in the context of ulcerative colitis.
Secondary objectives :
1. Efficacy of FMT on relapse rate at 24 weeks and 52 weeks.
2. Initiation of alternative treatment within 52 weeks after FMT.
3. FMT safety in the event of pouchitis.
4. Faecal microbiota modification in patients with recurrent chronic pouchitis in remission after antibiotic therapy and at 8 weeks of FMT from a healthy donor
5. Evolution of disability.
Two biocollections will be established and centralised at Nantes University Hospital. One will collect donor faeces samples and the other patient biopsies and faeces samples.
Abstract:
Results or projected end date :
first patient enrolment in May 2018
Partners involved :
IMAD
CHU de Nantes
Project lead contact :
Dr Caroline Trang-Poisson
Funding source :
PHRC