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

METHODS:

• 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)

RESULTS:

• 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

CONCLUSION:

• 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

Learn More – Primary Sources:

Effect of Oral Capsule– vs Colonoscopy-Delivered Fecal Microbiota Transplantation on Recurrent Clostridium difficile Infection: A Randomized Clinical Trial

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