Fecal microbiota transplantation is effective in preventing recurrent Clostridium difficile infection.
However, it is not known whether clinical efficacy differs by route of delivery.
Dr Dina Kao and colleagues determined whether fecal microbiota transplantation by oral capsule is noninferior to colonoscopy delivery in efficacy.
Noninferiority, unblinded, randomized trial conducted in 3 academic centers in Alberta, Canada.
The researchers enrolled a total of 116 adult patients with recurrent Clostridium difficile infection between 2014 and 2016, with follow-up to 2016.
The team found that the noninferiority margin was 15%.
|The noninferiority margin was 15%|
|Journal of the American Medical Association|
Participants were randomly assigned to fecal microbiota transplantation by capsule or by colonoscopy at a 1:1 ratio.
The research team's primary outcome was the proportion of patients without recurrent Clostridium difficile infection 12 weeks after fecal microbiota transplantation.
Secondary outcomes included serious and minor adverse events, changes in quality of life by the 36-Item Short Form Survey on a scale of 0 to 100, and patient perception on a scale of 1 to 10, and satisfaction on a scale of 1 (best) to 10 (worst).
Among 116 patients randomized, 91% completed the trial, with 57 patients randomized to the capsule group and 59 to the colonoscopy group.
The researchers noted that prevention of recurrent Clostridium difficile infection after a single treatment was achieved in 96% in both the capsule group, and the colonoscopy group, meeting the criterion for noninferiority.
One patient in each group died of underlying cardiopulmonary illness unrelated to fecal microbiota transplantation.
The team found that rates of minor adverse events were 5% for the capsule group vs 13% for the colonoscopy group.
The researchers observed no significant between-group difference in improvement in quality of life.
A significantly greater proportion of participants receiving capsules rated their experience as “not at all unpleasant”.
Dr Kao's team comments, "Among adults with recurrent Clostridium difficile infection, fecal microbiota transplantation via oral capsules was not inferior to delivery by colonoscopy for preventing recurrent infection over 12 weeks."
"Treatment with oral capsules may be an effective approach to treating recurrent Clostridium difficile infection."