Fecal Microbial Transplant by Oral Capsule Noninferior for CDI
FMT by capsule noninferior to FMT by colonoscopy for prevention of recurrent C. difficile infection
WEDNESDAY, Nov. 29, 2017 (HealthDay News) -- For patients with recurrent Clostridium difficile infection (RCDI), fecal microbial transplantation (FMT) with oral capsules is noninferior to FMT by colonoscopy, according to a study published in the Nov. 28 issue of the Journal of the American Medical Association.
Dina Kao, M.D., from the University of Alberta in Edmonton, Canada, and colleagues conducted a noninferiority, unblinded study involving 116 adult patients with RCDI at three academic centers. Participants were randomized to FMT by capsule or colonoscopy in a 1-to-1 ratio (57 and 59 patients, respectively).
The researchers found that prevention of RCDI after a single treatment was achieved by 96.2 percent of participants in the capsule and colonoscopy groups in the per-protocol analysis (difference, 0 percent), meeting the criterion for noninferiority. In each group, one patient died of cardiopulmonary illness, which was not related to FMT. The rates of minor adverse events were 5.4 and 12.5 percent for the capsule and colonoscopy groups, respectively. The improvement in quality of life did not differ significantly between the groups. The proportion of patients rating their experience as not at all unpleasant was significantly greater for those receiving capsules (66 versus 44 percent).
"When FMT is given by oral capsules, it can be administered in an office setting, which could substantially reduce cost and wait time. Complete economic evaluations are needed to understand the value and efficiency of FMT by oral capsule," the authors write.
Several authors disclosed financial ties to the pharmaceutical industry.