Table 6.
Study characteristics and outcomes of published randomized controlled trials of fecal microbial transplant for inflammatory bowel disease
Group | Moayyedi et al (2015) | Rossen et al (2015) |
n (active/placebo) | 75 (38/37) | 48 (23/25) |
Population | Adult patients; Mild-moderate UC | Adult patients; Mild-moderate UC |
Active arm | 50 mL enema (8 g healthy donor stool) | 500 mL nasoduodenal infusion (120 g healthy donor stool) |
Administered weekly × 6 wk | Administered at week 0, 3 | |
Control arm | Normal saline | Autologous FMT (patient’s stool) |
Inclusion of patients on Biologics | Yes, stable doses ≥ 12 wk | No |
Primary outcome | Clinical remission (partial Mayo endoscopic score < 3 and Mayo endo score = 0) at week 7 | Remission (SCCAI ≤ 2 + ≥ 1pt reduction in Mayo endoscopic score) at week 12 |
Clinical response (reduction in full Mayo score ≥ 3) | ||
Results | 9/38 (24%) treated with FMT vs 2/37 (5%) controls (P = 0.03) | 7/23 (30%) treated with FMT vs 5/25 (20%) controls (P = 0.51) |
Adapted from Grinspan et al[40] 2015. SCCAI: Simplified Clinical Colitis Activity Index.