Gastroenterology Research and Practice / 2022 / Article / Tab 1 / Review Article
Fecal Microbiota Transplants for Inflammatory Bowel Disease Treatment: Synthetic- and Engineered Communities-Based Microbiota Transplants Are the Future Table 1 Completed clinical trials investigating FMT as a potential therapy for IBD.
Feature of study Completed RCT trials Completed SGA trials Moayyedi et al. Rossen et al. Paramsothy et al. Costello et al. NCT02108821 NCT03106844 NCT01560819 NCT02049502 Study design Double-blind RCT Double-blind RCT RCT RCT Single group assignment Single group assignment Single group assignment Single group assignment Number of patients (placebo) 75 (37) 48 (25) 81 (40) 73 (35) 23 (NA) 50 (NA) 9 (NA) 8 (NA) Treatment regimen 6 FMTs 2 FMTs 40 FMTs 3 FMTs 1 FMT 1 FMT 20 FMT Single FMT Comparator (placebo) Water Autologous FMT Water Autologous FMT None None None None Route of administration Lower GI, enema Upper GI, duodenal tube Lower GI, retention Lower GI, retention Upper GI, jejunal intubation Lower GI, colonoscopy Retention enema Lower GI, sigmoidoscopy Stool donor per suspension Single donor Single donor Multiple donors Multiple donors NA NA Multiple donors Single donor Follow-up 6 weeks 12 weeks 8 weeks 8 weeks 26 weeks 8 weeks 4 weeks 13 weeks Primary endpoint Endoscopic remission Endoscopic remission Endoscopic response Endoscopic remission Occurrences of adverse events Recurrence of CDI in IBD patients Improvement in PUCAI score Improvement of pouchitis symptoms based on mPDAI Primary outcome FMT versus comparator 24% (9/38) versus 5% (2/37) 30% (7/23) versus 20% (5/25) 27% (11/41) versus 8% (3/40) 32% (12/38) versus 9% (3/35) 52.17% (12/23) 8.2% (4/49) Improvement in PUCAI score in all patients; 100% (9/9) Improvement in mPDAI score in all patients; 100% (9/9)
Abbreviations: FMT: fecal microbiota transplant; GI: gastrointestinal; RCT: randomized controlled trial; UC: ulcerative colitis; mPDAI: modified pouchitis disease activity index; PUCAI: Pediatric Ulcerative Colitis Activity Index; SGA: single group assignment.