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FMT not effective in active UC patients
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Fecal microbiota transplantation was not more effective compared with placebo in patients with active ulcerative colitis, according to research presented at the 10th Congress of ECCO in Barcelona, Spain.
In order to assess the safety and efficacy of FMT in patients with active UC, researchers from the Netherlands performed a randomized parallel group study involving 48 patients assigned to FMT from a healthy donor (n = 23) or their own feces used as a placebo (n = 25). FMT was administered by nasoduodenal tube at weeks 0 and 3, the follow-up period was 12 weeks, and all patients, physicians and endoscopists were masked, except for the nurse who performed randomization and prepared stool for FMT.
In the intent-to-treat analysis, 30.4% of patients who received FMT from a healthy donor achieved clinical remission (Simple Clinical Colitis Activity Index score ≤ 2) and endoscopic response (Mayo endoscopic score reduced by ≥ 1) compared with 20% of the placebo group (P = .51). Of the 37 patients who completed endoscopic follow-up (per-protocol analysis), 41.2% vs. 25% achieved clinical remission and endoscopic response (P = .29).
At 12 weeks, redundancy analysis demonstrated that fecal microbiota of responders in the group who received FMT from healthy donors overlapped with donor microbiota, specifically regarding Clostridium cluster XIVa, which was not observed in responders in the placebo group.
The researchers concluded that FMT was not superior to placebo for inducing clinical and endoscopic remission in moderately active UC patients, although FMT was associated with signature changes in the microbiota of responders. “Future studies should focus on mode of administration, matching for selected patients, as well as the observed shifts in microbiota composition in responders,” they wrote. – by Adam Leitenberger
Reference:
Rossen N, et al. Abstract OP003. Presented at: 10th Congress of ECCO; Feb. 18-21, 2015; Barcelona, Spain.
Disclosure: Rossen reports no relevant financial disclosures. Please see the ECCO website for all other researchers’ relevant financial disclosures.