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Anaerobically prepared FMT may be an effective ulcerative colitis treatment
Fecal microbiota transplantation suspensions prepared anaerobically could be an effective treatment for mild-to-moderate ulcerative colitis, according to research published in JAMA.
Samuel P. Costello, MBBS, of the department of gastroenterology at The Queen Elizabeth Hospital in Australia, and colleagues wrote that the success of FMT in treating Clostridium difficile infection has sparked interest in studying it as a treatment for other diseases. Although previous studies have produced varied results, the authors thought this could be due to how the suspensions were processed.
“Most colonic bacteria are obligate anaerobes and are extremely oxygen sensitive; thus, they may be diminished or eliminated when stool is processed under aerobic conditions,” they wrote. “If oxygen-sensitive organisms or their metabolites contribute to the clinical effect of FMT, preserving their viability may enhance the clinical effect of FMT.”
Researchers assessed the efficacy of short-duration, anaerobically prepared FMT therapy in a multicenter randomized trial comprising 73 adults in Australia. They enrolled patients at three tertiary centers between 2013 and 2016 and followed them for 12 months until June 2017.
They randomly assigned patients to receive either anaerobically prepared pooled donor FMT (n = 38) or autologous FMT (n = 35) via colonoscopy followed by two enemas over 7 days. The primary outcome was steroid-free remission, defined as a total Mayo score of no more than 2 with an endoscopic Mayo score of 1 or less at week 8. They also reassessed steroid-free remission at 12 months.
Sixty-nine patients completed the trial. Of the 38 patients who received the anaerobic FMT, 12 achieved the primary outcome (32%) compared with three of the 35 who received autologous FMT (9%; difference 23%; 95% CI, 4%–42%; OR = 5; 95% CI, 1.2–20.1). Of the patients in the anaerobic FMT cohort who achieved the primary endpoint at week 8, five maintained remission at 12 months.
In an accompanying editorial, Colleen R. Kelly, MD, of the Warren Alpert Medical school of Brown University, and Ashwin N. Ananthakrishnan, MD, MPH, of Massachusetts General Hospital, wrote that this and other studies of FMT in UC have found that broad microbial restoration is effective in about one-third of patients, which means it has a similar efficacy as systemic immunosuppression. They argue that more trials are needed to determine the right use of FMT for the management of UC, including which patients would benefit the most.
“Rather than stand-alone therapy, manipulation of the microbiome in UC is likely to be most effective when used in combination with agents, such as immunomodulators and biologics, which target the immune dysregulation underlying the disorder,” they wrote. “Given the signal of benefit seen so far, larger multicenter trials are an important next step and should be designed to answer questions about FMT delivery methods, mechanisms of action, and long-term durability of effects.” – by Alex Young
Disclosures: Costello reports receiving grants from the National Health and Medical Research Council and Gutsy Foundation, and fees from Ferring, Janssen, Microbiotica, Pfizer and Shire. Kelly reports serving as a site investigator for Finch Therapeutics and on the advisory board for Openbiome. Ananthakrishnan reports receiving grant support from the Chleck Family Foundation, the Crohn’s and Colitis Foundation, Gilead, the National Institutes of Health and Pfizer. Please see the full study for all other authors’ relevant financial disclosures.