Fecal microbial transplant for the treatment of pediatric inflammatory bowel disease

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.