A Randomised Placebo-Controlled Trial of Faecal Microbiota Transplantation in Patients with Chronic Pouchitis – MicroPouch study. MicroPouch

Objective: To investigate if treatment with non-pooled multi-donor faecal microbiota transplantation (FMT) for four weeks was superior to placebo for inducing clinical remission in patients with chronic pouchitis. Design: The study was a randomised placebo-controlled study with a 4-week intervention period and 12 months follow-up. Eligible patients with chronic pouchitis were recruited from five Danish hospitals. Patients were randomised to treatment with non-pooled multi-donor FMT derived from four faecal donors, or placebo. The study treatment was delivered by enema daily for two weeks followed by every second day for two weeks. Disease severity was accessed before and after treatment at 30-day follow-up, using the Pouchitis Disease Activity Index (PDAI). A PDAI <7 was considered equivalent to clinical remission. The gut microbiota in faecal samples from patients and donors was analysed using shotgun metagenomic sequencing.