A single fecal microbiota transplantation via colonoscopy appeared safe and effective for increasing microbial diversity in patients with active ulcerative colitis, according to the results of a prospective, open-label pilot study.
“Patients with ulcerative colitis typically have a lower diversity of microbes in their guts,” Randy S. Longman, MD, an assistant professor of medicine at Weill Cornell Medicine and a gastroenterologist at NewYork-Presbyterian/Weill Cornell Medical Center, said in a press release. “We know that a more diverse microbiota is correlated with better health, so increasing that diversity may be a key factor in the therapeutic efficacy of FMT for ulcerative colitis.”
While studies have established that FMT is an effective treatment for Clostridium difficile infection, its effectiveness for treating inflammatory bowel disease remains unclear.
Therefore, Longman and colleagues administered a fecal microbiota preparation to 20 patients with active ulcerative colitis, and assessed its safety and efficacy 4 weeks later. They used fecal microbiota preparations that each combined material from two of four donors screened and prepared at the public stool bank OpenBiome, to assess the efficacy of a high-diversity product and the effect of microbial composition on clinical response.
Overall, seven patients (35%) achieved clinical response, four (20%) were in remission and two (10%) of the patients who were in remission achieved mucosal healing at follow-up.
Three of the patients (15%) required escalation of care, but no serious adverse events occurred through 12 weeks.
Further, analysis of the patients’ fecal samples showed a significant increase in microbial diversity, and the patients’ microbiomes more closely resembled the donor microbiota compared with their own samples before FMT, regardless of whether they responded to the therapy or not.
They also found that the microbial composition of donor material correlated with clinical response in patients, as they were able to “segregate donor microbial characteristics with clinical outcome.”
Finally, to evaluate the effects of FMT on patients’ mucosal immunity, the investigators assessed fecal DNA and rectal biopsies to characterize microbiome and mucosal CD4+ T cells, and found a reduction in both Th1 and regulatory T-cells after FMT.
“We still want to know why this treatment helps some patients and not others so that we can find a safer and more reproducible treatment option for a greater majority of patients suffering from ulcerative colitis,” Carl Crawford, MD, an assistant professor of clinical medicine in the division of gastroenterology and hepatology at Weill Cornell Medicine, said in the press release.
Although further research is needed to determine the duration of benefit, the best therapeutic microbial composition, and the most effective delivery method, this study provides a proof-of-principle for two-donor FMT in active ulcerative colitis, the investigators concluded.
“We saw clear positive effects, both in terms of increased bacterial population and in clinical response,” Longman said in the press release. “This points to FMT as an exciting possible therapy for people with ulcerative colitis.” – by Adam Leitenberger
Disclosures: Several researchers report financial ties to Finch Therapeutics and OpenBiome.