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Multidonor fecal microbiota transplantation coupled with an anti-inflammatory diet (FMT-AID) induced remissions in patients with mild-to-moderate ulcerative colitis when added to standard medical therapy, a randomized trial in India found.

In a modified intention-to-treat analysis involving 66 patients, 65.7% of those in the FMT-AID group had a clinical response at 8 weeks compared with 35.5% of those assigned to optimized standard medical therapy alone (OR 3.5, 95% CI 1.3-9.6, P=0.01), reported Vineet Ahuja, MD, DM, of the All India Institute of Medical Sciences in New Delhi, and colleagues.

Additionally, 60% of patients in the FMT-AID group experienced remission versus 32.3% in those on standard medical therapy alone (OR 3.2, 95% CI 1.1-8.7, P=0.02), and 36.4% experienced deep remission versus 8.7%, respectively (OR 6.0, 95% CI 1.2-30.2, P=0.03).

Furthermore, 25% of patients in the FMT-AID group maintained deep remission compared with no patients in the standard medical therapy group at week 48 (P=0.007), they noted in .

Although endoscopic response was significantly higher in the FMT-AID group (51.5% vs 17.4%, P=0.012), the difference for endoscopic remission did not reach significance (36.4% vs 17.4%, P=0.15).

"The study further supports the potential of targeting the microbiome as a therapy for ulcerative colitis and also demonstrates that the benefit of FMT can be sustained," Joel Pekow, MD, of the University of Chicago Medicine, told 番茄社区app.

"The study also suggests that dietary therapy may be effective in maintaining healing in patients who receive FMTs," added Pekow, who was not involved in the study. "The treatment given in this study would be very difficult to replicate in clinical care, however, where seven weekly fecal transplants were given by endoscopy and patients adhered to a strict restrictive diet for 48 weeks."

Disruption of the intestinal microbiota contributes to the development of ulcerative colitis, Ahuja's group noted. While certain diets pose a risk for ulcerative colitis or could even be deadly, others may provide benefits. The anti-inflammatory diet works to improve the intestinal barrier, promoting healthy microbiota by increasing the consumption of fresh fruits and vegetables, and fermented foods, while avoiding red meats and gluten-based grains, among other foods.

A exploring FMT-AID among patients with refractory ulcerative colitis showed negative outcomes at 8 weeks, without investigating maintenance.

"Donors also have a very important influence on the success rates of FMT, and we have shown previously that in a cohort of healthy individuals, rural individuals had a than urban individuals, which formed the basis for recruitment of rural donors in the present study," Ahuja and team noted.

For this open-label study, which was conducted from September 2019 to March 2020, the authors enrolled 66 patients with mild-to-moderate ulcerative colitis; 35 were randomized to FMT-AID and 31 to optimized standard medical therapy for 7 weeks. Among responders at 8 weeks, those in the FMT-AID group continued to follow the diet while taking their baseline medications, while those in the control group continued only their baseline medications until week 48. Those on steroids (n=5) underwent dose tapering of 5 mg every 2 weeks, while topical steroid dosing was increased.

Baseline characteristics were similar between groups, including the use of concomitant medications. Along with steroids in most patients, all patients in each group were taking oral 5-aminosalicylic acid (5-ASA) and more than 90% were also taking 5-ASA topically as well.

Mean age was 35.7, and 60% were men. Over one-third had pancolitis. Mean Simple Clinical Colitis Activity Index and Ulcerative Colitis Endoscopic Index of Severity scores were 6 and 4, respectively.

At 48 weeks, 66.7% were highly adherent to the diet, while 33.4% were moderately adherent.

Common adverse events included mild abdominal pain (31.4% in the FMT-AID group vs 54.8% in the control group), bloating or flatulence (48.6% vs 38.7%), and diarrhea (37.1% vs 35.5%). No serious adverse events or deaths occurred.

Ahuja and team acknowledged limitations to their study, including the lack of placebo. In addition, COVID-19-related restrictions led to a smaller than desired sample size.

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