63rd Annual Conference of the Indian Society of Gastroenterology, ISGCON 2022—January 5th – 8th, 2023 in Jaipur

Objective Microbiome and dietary manipulation therapies are being explored for treating ulcerative colitis (UC).We aimed to examine the effect of fecal microbiota transplantation (FMT) and anti-inflammatory diet in inducing remission followed by long-term maintenance with anti-inflammatory diet in patients with mild-moderate UC.Design This open-labelled randomized controlled trial (RCT), randomized patients with mild-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) vs. optimized standard medical therapy (SMT).FMT-AID arm received 7 weekly colonoscopic infusions of freshly-prepared FMT from multiple rural donors (week 0-6) with anti-inflammatory diet.Baseline medications were optimized in SMT arm.Clinical responders (decline in SCCAI >3) at 8 weeks in both arms were followed till 48 weeks on baseline medications (with anti-inflammatory diet in FMT-AID arm).Primary outcome measures were clinical response and deep remission (clinical-SCCAI <2 and endoscopic-UCEIS <1) at 8 weeks, and deep remission and steroid free clinical remission at 48 weeks.Results Of 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; males-60.1%;disease duration-48 [IQR:24-84] months; pancolitis-34.8%;SCCAI-6 [IQR:5-7]; UCEIS-4 [IQR:3-5]) (Fig. 1).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,OR-3.5 [95% 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 till 48 weeks (6/24 [25%] vs. 0/27, p=0.007) (Figs. 2 and 3).Conclusion Multi-donor FMT with anti-inflammatory diet effectively induced deep remission in mild-moderate UC which was sustained with anti-inflammatory diet over one year.