Oral capsule fecal microbiota transplantation (FMT) was noninferior to colonoscopy in adults with recurrent Clostridium difficile infections (RCDI), according to a study published in JAMA.
Dina Kao, MD, of the Division of Gastroenterology, Department of Medicine, at the University of Alberta in Canada, and colleagues conducted a noninferiority, unblinded, randomized trial at 3 academic centers in Alberta to determine if the efficacy of oral capsule FMT was noninferior to colonoscopy delivery.
The authors monitored 116 patients for any signs of RCDI 12 weeks after FMT treatment (primary outcome) as well as any adverse experiences, changes to quality of life (QOL), and overall patient satisfaction (secondary outcomes). The median age was 58 years, 68% of patients were female, and 91% of all patients completed the trials.
Patients in both the oral capsule (n=57) and colonoscopy (n=59) groups had a 96.2% success rate after the week 12 follow-up. Rate difference between the two groups was 0%, indicating that the oral capsule was noninferior to colonoscopy delivery. In a follow-up sensitivity analysis, there was an 89.5% success rate (capsule group) and 96.6% success rate (colonoscopy group). In this test there was a -7.1% rate difference, confirming the noninferiority of the oral capsules.
QOL was assessed for only 103 patients but significantly increased after FMT treatment in both groups. In the preference and satisfaction secondary outcomes, 79% of patients stated that experienced unpleasantness was less than or equal to expected, and 97% said they would repeat their assigned method if needed. Of the participants who received the oral capsules, a significant majority (66%) reported that their experience was “not at all unpleasant.”
No infectious complications pertaining to FMT were observed in any of the patients. Minor adversities were noted in 12.5% of colonoscopy group patients and in 5.4% of the oral capsule group patients.
The noninferiority of the oral capsule can be beneficial in future pursuits for less invasive, economic procedures that are beneficial to patients, according to the researchers.
“Observing similar microbial composition in colonoscopy- and capsule-administered FMT supports the position that microbes alone can restore integrity to the intestinal ecosystem,” the authors commented.
Kao D, Roach B, Silva M, et al. Effect of oral capsule– vs colonoscopy-delivered fecal microbiota transplantation on recurrent Clostridium difficile infection: a randomized clinical trial. JAMA. 2017 Nov 28. doi:10.1001/jama.2017.17077