6/28/23, 10:41 PM Fecal transplant for ulcerative colitis Pathway Feedback Search Clinical Topics Home Studies Fecal transplant for ulcerative colitis Fecal transplant for ulcerative colitis Disease Ulcerative colitis Trial question What is the effect of anaerobically prepared fecal microbiota in patients with mild to moderately active ulcerative colitis? Study design Multi-center Open label RCT Population Characteristics of study participants 45.0% female N = 73 55.0% male 73 patients (33 female, 40 male) Inclusion criteria: patients with mild to moderately active ulcerative colitis Key exclusion criteria: previous colonic surgery, gastrointestinal infection, pregnancy, stool infections, anticoagulant therapy, or current use of antibiotics or probiotics Interventions N=38 pooled donor fecal transplant (200 mL via colonoscopy, then 2 enemas over 7 days) N=35 autologous fecal transplant (200 mL via colonoscopy, then 2 enemas over 7 days) Primary outcome Steroid-free remission at 8 weeks 32.0 % 32 24 0 % https://web.pathway.md/studies/recDUZIwumy12rA1W 1/2 6/28/23, 10:41 PM 24.0 % Fecal transplant for ulcerative colitis Pathway 16.0 % Significant increase 9 8.0 % NNT = 4 0.0 % Pooled donor fecal transplant Autologous fecal transplant Significant increase in steroid-free remission at 8 weeks (32% vs. 9%; OR 5, 95% CI 1.2 to 20.1) Secondary outcomes Significant increase in clinical response at 8 weeks (55% vs. 23%; ARD 32, 95% CI 10 to 54) Significant increase in clinical remission at 8 weeks (47% vs. 17%; ARD 30, 95% CI 7 to 51) No significant difference in steroid-free endoscopic remission at 8 weeks (ARD 11, 95% CI -1 to 27) Safety outcomes No significant difference in serious adverse events (3 vs. 2). Conclusion In patients with mild to moderately active ulcerative colitis, pooled donor fecal transplant was superior to autologous fecal transplant with respect to a steroid-free remission at 8 weeks. Reference Costello SP, Hughes PA, Waters O et al. Effect of Fecal Microbiota Transplantation on 8-Week Remission in Patients With Ulcerative Colitis: A Randomized Clinical Trial. JAMA. 2019 Jan 15;321(2):156-164. Open reference URL https://web.pathway.md/studies/recDUZIwumy12rA1W 2/2