Characteristics and Outcomes of Clinical Trials on Fecal Microbiota Transplantation for Ulcerative Colitis
| Study | DA N (FMT/control) | Control intervention | Donor | Dosage | Frequency | Delivery | F/U | Remission |
|---|---|---|---|---|---|---|---|---|
| Moayyedi et al.26 (2015) | [Mayo clinic score ≥4 with an endoscopic Mayo clinic score ≥1] 75 (38/37) | Water enema | Single | 50 g stool in 300 mL water | 6 (weekly) | Enema | 7 weeks | FMT 24%, control 5%, p=0.03 |
| Rossen et al.27 (2015) | [SCCAI ≥4 and ≤11] 48 (23/25) | Autologous fecal microbiota | Single | ≥60 g stool in 500 mL saline | 2 (at week 0 and 3) | Naso-duodenal | 12 weeks | FMT 30.4%, control 20.0%, p=0.51 |
| Paramsothy et al.28 (2017) | [Mayo score: 4-10] 81 (41/40) | Saline enema | Multi-donor | 37.5 g stool in 150 mL saline | 40 (1 colonoscopic infusion then enemas 5/week for 8 weeks) | Colonoscopy→ enema | 8 weeks | FMT 27%, control 8%, p=0.021 |
| Costello et al.29 (2019) | [Total Mayo score 3-10 and an endoscopic subscore of ≥2] 73 (38/35) | Autologous stool | Multi-donor | 50 g stool in 200 mL saline via colonoscopy +25 g stool in 100 mL saline via enema | 3 (at week 0 colonoscopy, at week 1 two enemas) | Colonoscopy→ enema | 8 weeks | FMT 32%, control 9%, p=0.02 |
| Sood et al.30 (2019) | [Mayo score 4-10] 61 (31/30) | Saline+SOC | Single | 100 g stool in 200 mL saline | 7 (at weeks 0, 8, 16, 24, 32, 40 and 48) | Colonoscopy | 48 weeks | FMT+SOC 87.1%, control+SOC 66.7%, p=0.11 |
| Sood et al.31 (2021) | [Mayo clinic score ≥6 and Mayo endoscopic subscore ≥2] 93 patients (FMT group) | None (no control group) | Single | 80 g stool in 200 mL saline | 7 (at weeks 0, 2, 6, 10, 14, 18 and 22) | Colonoscopy | 30 weeks | 61.29% in FMT group |
DA, disease activity; SSCAI, simple clinical colitis activity index; SOC, standard of care (5-ASA with/without azathioprine).