Dina Kao, MD, of Alberta, Canada-based University of Alberta, conducted a noninferiority, unblinded, randomized trial in three academic centers in Canada. Approximately 116 adult patients with recurrent Clostridium difficile infection were enrolled between October 2014 and September 2016.
Exactly 105 patients completed the trial with 57 assigned to the capsule group and 59 to the colonoscopy group.
Here’s what they found:
1. RCDI prevention was achieved in 96.2 percent of patients in both the capsule and the colonoscopy group after one treatment.
2. One patient in each group died of an underlying cardiopulmonary illness unrelated to FMT.
3. Adverse events were lower in the capsule group (5.4 percent) than in the colonoscopy group (12.5 percent).
4. There was no difference in quality of life.
5. Sixty-six percent of patients in the capsule group said their experience was “not at all unpleasant.”
Researchers concluded, “Among adults with RCDI, FMT 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 RCDI.”
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