Table 3 Characteristics of the primary RCTs of included reviews
Study | Country | No. Sample size (n1/n2) | Severity | Intervention of FMT | Intervention of control | Concomitant treatment | Duration to follow-up | Combined clinical and endoscopic remission n/response (n1/n2) | Clinical remission/response (n1/n2) | Endoscopic remission/response (n1/n2) | Serious adverse events (n1/n2) |
|---|---|---|---|---|---|---|---|---|---|---|---|
Rossen, 2015 [32] | Netherlands | 23/25 | SCCAI score 4–11 | Fresh single-donor FMT; administered through nasoduodenal tube at time 0 then at week 3 | Autologous stool administered through nasoduodenal tube | Stable maintenance medication (5-ASA, thiopurines), prednisolone #10 mg/d | Week 12 | 7/5 | 18/21 | 10/11 | 2/2 |
Moayyedi, 2015 [33] | Canada | 38/37 | Mayo score ≥ 4 | Fresh and frozen single-donor FMT; administered through weekly enema | Water retention enema | Stable maintenance medication (5-ASA, thiopurines, methotrexate, anti-TNF, steroids) | Week 7 | 15/9 | 24/11 | 9/3 | 3/2 |
Costello, 2019 [34] | Australia | 38/35 | Mayo score 3–10 | Frozen pooled-donors FMT; administered by means of colonoscopy at time 0, then 2 enemas at day 7 | Aerobically prepared, autologous stool; administered by means of colonoscopy at time 0, then 2 enemas at day 7 | Stable maintenance medication (5-ASA, thiopurines, methotrexate, anti-TNF, vedolizumab), prednisolone #20 mg/d with mandatory wean | Week 8 | 12/3 | 39/13 | 21/6 | 3/2 |
Paramsothy, 2017 [35] | Australia | 41/40 | Mayo score 4–10 | Frozen pooled-donors FMT; administered by means of colonoscopy at time 0, then 5 enemas per week for 8 weeks | Saline + odorant + food colouring in enema | Stable maintenance medication (5-ASA, thiopurines, methotrexate), prednisolone #20 mg/d with mandatory wean | Week 8 | 11/3 | 40/17 | 18/7 | 2/1 |
Crothers, 2018 [36] | USA | 7/8 | Mayo score 4–10 | Frozen and fresh pooled-donors FMT; administered by means of colonoscopy at time 0, followed by daily FMTc (0.375 g stool) | Sham FMT and daily placebo capsules | N/A | Week 18 | 3/0 | NR | 6/0 | NR |
Mahajan, 2018 [37] | India | 22/21 | Mayo score 4–10 | Administered by means of colonoscopy | Placebo | N/A | Week 48 | 18/8 | 19/14 | NR | NR |
Sood, 2019 [38] | India | 31/30 | Mayo score 4–10 | Frozen single-donor FMT; administered by means of colonoscopy at weeks 0, 8, 16, 24, 32, 40 and 48 | Placebo, administered by means of colonoscopy at weeks 0, 8, 16, 24, 32, 40 and 48 | Stable maintenance medication (5-ASAs, corticosteroids, thiopurines) | Week 48 | NR | 27/20 | 18/8 | 0/1 |
Crothers, 2021 [39] | USA | 6/6 | Mayo score 4–10 | Frozen single-donor FMT; administered by means of colonoscopy at weeks 0, followed by a dose of 1 daily 550μL FMT capsule, for 12 weeks | Sham colonoscopic infusion and sham capsules | Stable maintenance medication (anti-TNFα, immunomodulators, 5-ASA, methotrexate) | Week 12 | 2/0 | 5/3 | NR | 1/1 |
Březina, 2021 [40] | Czech Republic | 21/22 | Mayo score 4–10 | Frozen single-donor FMT; administered 10 FMT infusions, five in the first week and once weekly in the following 5 weeks | A standard-of-care regimen that included 4 g mesalamine enemas daily for 2 weeks and then every other day until the end of week 6 | Stable maintenance medication (5-ASAs, prednisone, thiopurines) | Week 12 | NR | 27/20 | 3/3 | 22/21 |
Pai, 2021 [41] | Canada | 12/12 | N/A | Frozen pooled-donors FMT; retention enema | Placebo | Stable maintenance medication (anti-TNFα, immunomodulator) | Week 30 | NR | 5/4 | NR | 5/1 |
Sarbagili, 2022 [42] | Israel | 19/15 | SCCAI score 5–11 | Frozen single-donor FMT; administered by means of colonoscopy on day 1, then revived rectal enemas from the same donor on days 2 and 14 | With an ulcerative colitis exclusion diet for 12 weeks | Stable maintenance medication (5-ASA, steroids, biologics, immunomodulators) | Week 8 | NR | 4/6 | 3/4 | 0/0 |
Haifer, 2022 [43] | Australia | 15/20 | Mayo score 4–10 | Frozen single-donor FMT; oral lyophilised FMT for 8 weeks | Oral placebo capsules for 8 weeks | Stable maintenance medication (5-ASA, thiopurines, methotrexate, prednisolone, biologics) | Week 8 | 8/3 | 22/14 | 15/11 | 2/1 |