Fecal Microbiota Transplant for C. difficile – Oral Capsules or Colonoscopy?

BACKGROUND AND PURPOSE:

Clostridium difficile infection (CDI) is a major cause of morbidity and mortality, particularly in the setting of recurrent CDI
Fecal microbiota transplant (FMT) is the most effective therapy for recurrent CDI
Uncontrolled studies suggest that colonoscopy is a better route of FMT delivery compared to oral
Kao et al. (JAMA, 2017) sought to compare the efficacy of FMT delivered by oral capsule versus colonoscopy

Noninferiority, unblinded, randomized trial of adult patients with recurrent CDI
Patients were randomly assigned to receive either capsule or colonoscopy
Primary outcome
- Proportion of patients with recurrent CDI 12 weeks after FMT
Secondary outcomes
- Serious and minor adverse events, changes in quality of life by the 36-Item Short Form Survey on a scale of 0 (worst) to 100 (best), and patient perception on a scale of 1 (not at all unpleasant) to 10 (extremely unpleasant) and satisfaction on a scale of 1 (best) to 10 (worst)

57 patients randomized to the capsule group and 59 to the colonoscopy group
- Mean age was 58 years; 68% were women
Prevention of recurrent CDI after a single treatment was achieved in 96.2% in both the capsule group (51/53) and the colonoscopy group (50/52), meeting the criterion for noninferiority
Rates of minor adverse events were 5.4% for the capsule group vs 12.5% for the colonoscopy group
A significantly greater proportion of participants receiving capsules rated their experience as “not at all unpleasant” (66% vs 44%; difference, 22% [95% CI, 3%-40%]; P = .01)
There was no significance between-groups in improvement in quality of life

FMT oral capsule was not inferior to delivery via colonoscopy over 12 weeks
Patients reported no difference in quality of life improvement between oral and colonoscopy but had fewer associated adverse events and lower reported levels of unpleasantness