Safety and Efficacy of Fecal Microbiota Transplants for the Treatment of Clostridium difficile at a Tertiary Care Academic Medical Center

Background: Clostridium difficile infections (CDI) pose significant challenges to patients and the healthcare system. Fecal microbiota transplants (FMT) represent one treatment option for patients with multiple recurrences or severe CDI infections unresponsive to antibiotic therapy. Our aim was to characterize patients undergoing FMT for the treatment of CDI and their clinical outcomes.

Methods: We retrospectively evaluated patients who underwent first FMT using a frozen sample for the treatment of CDI between May 2014 and August 2015. Data collected included baseline demographics, number of CDI recurrences prior to FMT, CDI treatment failures, time to clinical response post-FMT, clinical resolution at 8 weeks post-FMT, number of repeat FMTs, number of CDI-related admissions post-FMT, mortality and FMT adverse effects. Descriptive statistics, Fisher Exact test and Mann-Whitney U test were utilized.

Results: Twenty-three patients met inclusion criteria during the study period. Of the 22 patients with follow-up data available, 14 (63.6%) patients experienced clinical resolution of CDI at 8 weeks following FMT. Median time to clinical response was one day (range 1-5 days). Clinically significant differences between FMT failures and successes included higher BMI (27.7 vs 22.7, p = 0.07), more non-CDI antibiotic use prior to FMT (50% vs 21.4%, p = 0.34) and after FMT (62.5% vs 35.7%, p = 0.38), and more inpatients (75% vs 28.6%, p = 0.074) in the failure group. Overall, seven patients (31.8%) were hospitalized post-FMT for CDI-related complications and four patients (17%) underwent repeat FMT within six months of initial FMT. Three patients (13.6%) died during the study period but none were attributed to CDI. The most commonly reported adverse effects were diarrhea that did not meet criteria for active CDI (45.5%), abdominal discomfort (36.4%), and nausea (22.7%).

Conclusion: Adverse effects were mild with no serious complications. CDI failure post-FMT was more common in the inpatient versus outpatient setting and in those receiving non-CDI antimicrobials but factors contributing to FMT failure should be further evaluated in larger studies.