Colon to Rectum
Gut. 2022;71(12):2401–13
Fecal microbiota transplantation with anti-inflammatory diet (FMT-AID) followed by anti-inflammatory diet alone is effective in inducing and maintaining remission over 1 year in mild-to-moderate ulcerative colitis: A randomized controlled trial
Objective: Microbiome and dietary manipulation therapies are being explored for treating ulcerative colitis (UC). The authors aimed to examine the efficacy of multidonor fecal microbiota transplantation (FMT) and anti-inflammatory diet in inducing remission followed by long-term maintenance with anti-inflammatory diet in patients with mild-to-moderate UC.
Design: This open-labeled randomized controlled trial (RCT) randomized patients with mild-to-moderate (Simple Clinical Colitis Activity Index [SCCAI] 3–9) endoscopically active UC (Ulcerative Colitis Endoscopic Index of Severity (UCEIS) > 1) on stable baseline medications in 1:1 ratio to FMT and anti-inflammatory diet (FMT-AID) versus optimized standard medical therapy (SMT). The FMT-AID arm received 7 weekly colonoscopic infusions of freshly prepared FMT from multiple rural donors (weeks 0–6) with anti-inflammatory diet. Baseline medications were optimized in the SMT arm. Clinical responders (decline in SCCAI ≥ 3) at 8 weeks in both arms were followed until 48 weeks on baseline medications (with anti-inflammatory diet in the FMT-AID arm). Primary outcome measures were clinical response and deep remission (clinical, SCCAI < 2; endoscopic, UCEIS < 1) at 8 weeks, and deep remission and steroid-free clinical remission at 48 weeks.
Results: Of the 113 patients screened, 73 were randomized, and 66 were included in (35 FMT-AID; 31 SMT) modified intention-to-treat analysis (age, 35.7 ± 11.1 years; male, 60.1%; disease duration, 48 [interquartile range {IQR}, 24–84] months; pancolitis, 34.8%; SCCAI, 6 [IQR, 5–7]; UCEIS, 4 [IQR, 3–5]). Baseline characteristics were comparable. FMT-AID was superior to SMT in inducing clinical response (23/35 [65.7%] vs. 11/31 [35.5%], p = 0.01, odds ratio [OR] = 3.5 [95% confidence interval {CI}: 1.3–9.6]), remission (21/35 [60%] vs. 10/31 [32.3%], p = 0.02, OR = 3.2 [95% CI: 1.1–8.7]) and deep remission (12/33 [36.4%] vs. 2/23 [8.7%], p = 0.03, OR = 6.0 [95% CI: 1.2–30.2]) at 8 weeks. Anti-inflammatory diet was superior to SMT in maintaining deep remission until 48 weeks (6/24 [25%] vs. 0/27, p = 0.007).
Conclusion: Multidonor fecal microbiota transplantation with anti-inflammatory diet effectively induced deep remission in mild-to-moderate ulcerative colitis which was sustained with anti-inflammatory diet over 1 year.