Table 1. Characteristics and methodological quality of the included studies.
Study | Treatmet arms |
No. of patients (exp. arm/con. arm) |
Baseline characteristics |
Dosage | Remission criteria |
Trial period | Concomitant treatment | Clinical trials.gov number | Jadad score |
---|---|---|---|---|---|---|---|---|---|
Paramsothy 2016 | FMT vs. placebo |
42/43 | MCS 4–10 Endoscopic Mayo score ≥ 1 |
Enema 150 ml Quing i w. | Mayo subscores ≤ 1 | 8w | 5-ASA, thiopurine, and methotrexate |
NCT01896635 | 7 |
Costello 2017 | FMT vs. placebo |
38/35 | MCS 3–10 Endoscopic Mayo score ≥ 2 |
Colonoscopy q.w. | SCCAI ≤ 2 | 8w | NA | ACTRN12613000236796 | 5 |
Moayyedi 2015 | FMT vs. placebo |
38/37 | MCS ≥ 4 Endoscopic Mayo score ≥ 1 |
Enema 50 ml q.w. | MCS ≤ 2 with an endoscopic Mayo score of 0 | 6w | continued on the drug at a stable dose |
NCT01545908 | 5 |
Rossen 2015 | FMT vs. placebo |
23/25 | MCS ≥ 4, ≤ 11 Sigmoidoscopic score ≥ 1 | NA | SCCAI ≤ 2 | 12w | NA | NCT01650038 | 4 |
Tursi 2010 | VSL#3 vs. placebo |
71/73 | UCDAI score 3–8 Sigmoidoscopic score ≥ 2 |
Two sachets b.i.d. | UCDAI ≤ 2 | 8w | continued on the drug at a stable dose |
NCT09515548 | 6 |
Sood 2009 | VSL#3 vs. placebo |
77/70 | UCDAI score 3–9 Sigmoidoscopic score ≥ 2 |
Two sachets b.i.d. | UCDAI ≤ 2 | 12w | continued on the drug at a stable dose |
CTRI2008/091/00076 | 7 |
Ng 2010 | VSL#3 vs. placebo |
14/14 | UCDAI score 3–8 | Two sachets b.i.d. | UCDAI ≤ 2 | 8w | Corticosteroids reduced by 5 mg each week | NA | 3 |
Exp. arm: experimental arm; Con. arm: control arm; SCCAI: Simple Clinical Colitis Activity Index; UCDAI: Ulcerative Colitis Disease Activity Index; MCS: Mayo clinical score; Quing i w.: Five times a week; q.w.: once a week; b.i.d.: Twice a day; NA: not available; w: week; CTRI: Clinical Trial Registry
In modified Jadad scale, studies with scores higher than 5 were considered good quality.