Colleen R. Kelly, MD; Alexander Khoruts, MD; Christopher Staley, PhD; Michael J. Sadowsky, PhD; Mortadha Abd, MD; Mustafa Alani, MD; Brianna Bakow, BA; Patrizia Curran, MD; Joyce McKenney, MS; Allison Tisch, NP; Steven E. Reinert, MS; Jason T. Machan, PhD; Lawrence J. Brandt, MD

Ann Intern Med. 2016 Nov. 1; 165(9):609-616

Abstract available at: https://www.ncbi.nlm.nih.gov/pubmed/27547925

• Fecal microbiota transplantation (FMT) has become the treatment of choice for multiple recurrences of Clostridium difficile infection (CDI), based on numerous case series showing high recurrence rates after continued antibiotic therapy and high cure rates after FMT.
• The current study is the first randomized, blinded, controlled trial of FMT for recurrent CDI. In two centers, 46 patients with three or more recurrences and who had received at least a full course of vancomycin for their most recent acute episode were randomized to receive donor FMT or autologous FMT administered by colonoscopy. Donors were healthy volunteers or individuals chosen by patients, and all underwent infection screening before donating.
• The cure rate was 91% with donor FMT versus 63% with autologous FMT (P=0.04). However, the autologous FMT cure rate was 43% at one center and 90% at the second center. The 9 patients with recurrence after autologous FMT were cured after receiving donor FMT.
• Analysis of fecal microbiota pre- and post-transplant indicated that successful FMT generally corrected pre-transplant dysbiosis.

Conclusion: This study provides clear proof of the efficacy of FMT, but of course, the high rate of cure with autologous FMT at one center is of great interest. The authors speculate that high rates of previous treatment with fidaxomicin and long courses of vancomycin in patients at that center caused some of the patients to be cured before enrollment. CDI can induce post-infectious irritable bowel syndrome (IBS), and some of the patients might have been colonized by C. difficile but had symptoms related to IBS.