Colon to Rectum

Gut. 2022;71(12):2401–13

Kedia S, Virmani S, Vuyyuru SK, Kumar P, Kante B, Sahu P, Kaushal K, Farooqui M, Singh M, Verma M, Bajaj A, Markandey M, Sachdeva K, Das P, Makharia GK, Ahuja V

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.

Dr. V. Ahuja, Department of Gastroenterology, All India Institute of Medical Sciences, New Delhi, India,

DOI: DOI: 10.1136/gutjnl-2022-327811

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