Fecal microbiota therapy that was prepared anaerobically from pooled donor material was more effective than placebo at 1 week for inducing remission in patients with active ulcerative colitis, according to data from an Australian randomized controlled trial presented at the 12th Congress of the European Crohn’s and Colitis Organization.
To investigate whether FMT with a lower treatment burden is effective in UC, investigators randomly assigned 73 patients with active UC to receive either anaerobically prepared donor stool pooled from three or four donors (n = 38) or autologous FMT as placebo (n = 35), which were frozen, thawed and given by colonoscopy on the first day of treatment, followed by two enemas by day 7 of treatment. Patients were also required to taper oral corticosteroids, and those who could not were considered FMT non-responders.
Intention-to-treat analysis showed that 32% of the autologous FMT treatment group achieved steroid-free remission at week 8 vs. 9% of the placebo group (P = .02), which served as the study’s primary endpoint.
Further, per-protocol analysis showed that 34% (of 35 FMT patients) vs. 9% (of 34 placebo patients) achieved steroid-free remission at week 8 (P = .02).
Intention-to-treat analysis also showed clinical response rates were 55% vs. 20% (P < .01) and clinical remission rates were 50% vs. 17% (P < .01). Finally, steroid-free endoscopic remission rates were 55% vs. 17% (P < .01).
The likelihood of achieving the primary endpoint was not linked to the extent or duration of disease, the researchers noted. Serious adverse events occurred in comparable frequency between groups.
The investigators concluded that this low-dose, short-duration FMT protocol was more effective than placebo for inducing both clinical and endoscopic remission at 8 weeks in patients with active UC. – by Adam Leitenberger
Costello S, et al. Abstract OP036. Presented at: ECCO Congress; February 15-18, 2017. Barcelona.
Disclosures: Costello reports grants from NHMRC and Gutsy, and personal fees from Merck Sharp and Dohme. Please see the ECCO disclosure database for a full list of all other researchers’ relevant financial disclosures.