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FMT induces remission in resistant ulcerative colitis

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Intense multi-donor fecal microbiota transplantation administered via colonoscopy and enema effectively induced clinical and endoscopic remission in patients with resistant active ulcerative colitis, according to the results of a randomized, placebo-controlled trial presented at the European Crohn’s and Colitis Organization’s Congress.

Researchers performed a double blind study of 81 patients with active UC resistant to standard therapies at three Australian centers. They randomly assigned patients to FMT or placebo colonoscopic infusion on day 1 followed by FMT or placebo enemas 5 days per week for 8 weeks. The researchers acquired each FMT enema from three to seven unrelated donors, and patients who were taking corticosteroids weaned and stopped.

Steroid-free clinical remission and endoscopic remission or response at week 8 served as the composite primary endpoint. Steroid-free clinical remission, clinical response, endoscopic remission, endoscopic response, quality of life and safety served as secondary endpoints. Analyses were intention to treat and patients in the placebo group were offered 8 weeks of open-label treatment at the end of the study period.

Eleven of 41 patients (27%) who received FMT achieved the primary endpoint vs. three of 40 patients (8%) who received placebo (P = .02). Moreover, significantly more FMT patients achieved steroid-free clinical remission (44% vs. 20%; P = .02) and clinical response (54% vs. 23%; P < .01). Steroid-free endoscopic remission rates were 17% vs. 8% (P = .19) and endoscopic response rates were 37% vs. 10% (P < .01).

Adverse events were comparable between groups, and three serious adverse events occurred (worsening of colitis in two FMT patients, one of whom required colectomy for severe UC, and one placebo patient).

Twenty-seven percent of the 37 placebo patients who then received open-label FMT achieved the primary endpoint, 46% achieved clinical remission and 24% achieved endoscopic remission.

“This largest controlled trial of FMT has demonstrated that intense multi-donor colonoscopic enema FMT is effective in inducing strictly defined clinical and endoscopic remission in patients with resistant active ulcerative colitis,” the researchers wrote. – by Adam Leitenberger

Reference:

Paramsothy S, et al. Abstract OP017. Presented at: ECCO Congress; March 16-19, 2016. Amsterdam.

Disclosure: Paramsothy reports grants from Abbott/GESA IBD Clinical Research Grant, BROAD Medical Research Program, Sunshine Coast Wishlist Research Grant Scheme and UNSW Gold Star Award, and other financial relationships with National Health and Medical Research Council Medical Postgraduate Research Scholarship during the conduct of the study. Please see the ECCO disclosures database for all other researchers’ relevant financial disclosures.