Fecal microbiota transplantation (FMT) using oral capsules as the delivery method has been shown to be noninferior to delivery using colonoscopy for the treatment of Clostridium difficile infection, but with a significantly lower price tag.
In an unblended noninferiority trial, published in the Nov. 28 issue of JAMA, 116 adults with at least three documented episodes of C. difficile infection were randomized to either 360 mL of fecal slurry delivered to the cecum via colonoscopy or to 40 capsules of processed fecal microbiota swallowed under direct observation.
, MD, of the department of medicine at the University of Alberta, Edmonton, and coauthors commented that the response rate with the capsules was higher than that seen in other studies of fecal microbiota capsules, which they suggested may partly be due to the larger amount of donor stool used in the study: 80-100 g, compared with 17 g and 25 g used in other studies.
“The higher efficacy observed in this study suggests a dose-dependent response to FMT, and a benefit of bowel lavage prior to FMT, because residual vancomycin was detected up to 8 days despite its discontinuation,” they wrote.
Both treatment modalities achieved similar quality of life improvements. Both groups reported major improvements in domains including physical and emotional health, physical and social functioning, and general health, with no significant differences between the two arms of the study.
The cost per treatment in the colonoscopy group was $874 per patient, compared with $308 per patient in the capsule group.
“Although colonoscopy delivery is more invasive, resource intensive, costly, and inconvenient for patients, it has the advantage of identifying alternative diagnoses,” the authors wrote. “Conversely, when FMT is given by oral capsules, it can be administered in an office setting, which could substantially reduce cost and wait time.”
Both groups also showed significantly improved gut microbiota diversity, which approached that of the donor just 1 week after administration of the treatment.
While 30% of patients characterized FMTs as “unpleasant, gross, or disgusting,” 79% of participants said the unpleasantness was the same or less than anticipated, and 97% said they would undergo the same treatment by the same delivery method again if needed.
However, significantly more patients in the capsule group described their experience as “not at all unpleasant,” compared with the colonoscopy group (66% vs. 44%; 95% CI, 3%-40%; P = .01).
There were no colonic perforations seen in the colonoscopy group, and no infectious complications relating to the treatment in either group. One patient in each group died of underlying cardiopulmonary illness that was unrelated to the treatment, and the rate of minor adverse events was 5.4% in the capsule group and 12.5% in the colonoscopy group.
The authors acknowledged that the lack of a placebo group in the study meant they were not able to measure the size of the effect of fecal microbiota transplantation by either route. One earlier trial had also shown a placebo response rate of 45%.
The study was funded by Alberta Health Services and the University of Alberta Hospital Foundation. Four authors declared grants and other funding from the study funder and the pharmaceutical industry.
The AGA Center for Gut Microbiome Research and Education serves as a virtual “home” for AGA activities related to the gut microbiome, including the AGA FMT National Registry, which will assess short- and long-term patient outcomes associated with FMT. Learn more at http://www.gastro.org/about/initiatives/aga-center-for-gut-microbiome-research-education.