title: Effect of Fecal Microbiota Transplantation on Recurrence in Multiply Recurrent Clostridium difficile Infection: A Randomized Trial.
abstract: BACKGROUND
  To date, evidence for the efficacy of fecal microbiota transplantation (FMT) in recurrent Clostridium difficile infection (CDI) has been limited to case series and open-label clinical trials.
  
  
  OBJECTIVE
  To determine the efficacy and safety of FMT for treatment of recurrent CDI.
  
  
  METHODS
  Randomized, controlled, double-blind clinical trial. (ClinicalTrials.gov: NCT01703494).
  
  
  METHODS
  Two academic medical centers.
  
  
  METHODS
  46 patients who had 3 or more recurrences of CDI and received a full course of vancomycin for their most recent acute episode.
  
  
  METHODS
  Fecal microbiota transplantation with donor stool (heterologous) or patient's own stool (autologous) administered by colonoscopy.
  
  
  METHODS
  The primary end point was resolution of diarrhea without the need for further anti-CDI therapy during the 8-week follow-up. Safety data were compared between treatment groups via review of adverse events (AEs), serious AEs (SAEs), and new medical conditions for 6 months after FMT. Fecal microbiota analyses were performed on patients' stool before and after FMT and also on donors' stool.
  
  
  RESULTS
  In the intention-to-treat analysis, 20 of 22 patients (90.9%) in the donor FMT group achieved clinical cure compared with 15 of 24 (62.5%) in the autologous FMT group (P = 0.042). Resolution after autologous FMT differed by site (9 of 10 vs. 6 of 14 [P = 0.033]). All 9 patients who developed recurrent CDI after autologous FMT were free of further CDI after subsequent donor FMT. There were no SAEs related to FMT. Donor FMT restored gut bacterial community diversity and composition to resemble that of healthy donors.
  
  
  CONCLUSIONS
  The study included only patients who had 3 or more recurrences and excluded those who were immunocompromised and aged 75 years or older.
  
  
  CONCLUSIONS
  Donor stool administered via colonoscopy seemed safe and was more efficacious than autologous FMT in preventing further CDI episodes.
  
  
  BACKGROUND
  National Institute of Diabetes and Digestive and Kidney Diseases.
authors.affiliation: From Warren Alpert Medical School of Brown University, Miriam Hospital, and Lifespan Hospital System, Providence, Rhode Island; University of Minnesota, Minneapolis/St. Paul, Minnesota; Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York; and University of Rhode Island, Kingston, Rhode Island.
authors.forename: Colleen R
authors.initials: CR
authors.lastname: Kelly
authors.affiliation: From Warren Alpert Medical School of Brown University, Miriam Hospital, and Lifespan Hospital System, Providence, Rhode Island; University of Minnesota, Minneapolis/St. Paul, Minnesota; Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York; and University of Rhode Island, Kingston, Rhode Island.
authors.forename: Alexander
authors.initials: A
authors.lastname: Khoruts
authors.affiliation: From Warren Alpert Medical School of Brown University, Miriam Hospital, and Lifespan Hospital System, Providence, Rhode Island; University of Minnesota, Minneapolis/St. Paul, Minnesota; Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York; and University of Rhode Island, Kingston, Rhode Island.
authors.forename: Christopher
authors.initials: C
authors.lastname: Staley
authors.affiliation: From Warren Alpert Medical School of Brown University, Miriam Hospital, and Lifespan Hospital System, Providence, Rhode Island; University of Minnesota, Minneapolis/St. Paul, Minnesota; Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York; and University of Rhode Island, Kingston, Rhode Island.
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Sadowsky
authors.affiliation: From Warren Alpert Medical School of Brown University, Miriam Hospital, and Lifespan Hospital System, Providence, Rhode Island; University of Minnesota, Minneapolis/St. Paul, Minnesota; Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York; and University of Rhode Island, Kingston, Rhode Island.
authors.forename: Mortadha
authors.initials: M
authors.lastname: Abd
authors.affiliation: From Warren Alpert Medical School of Brown University, Miriam Hospital, and Lifespan Hospital System, Providence, Rhode Island; University of Minnesota, Minneapolis/St. Paul, Minnesota; Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York; and University of Rhode Island, Kingston, Rhode Island.
authors.forename: Mustafa
authors.initials: M
authors.lastname: Alani
authors.affiliation: From Warren Alpert Medical School of Brown University, Miriam Hospital, and Lifespan Hospital System, Providence, Rhode Island; University of Minnesota, Minneapolis/St. Paul, Minnesota; Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York; and University of Rhode Island, Kingston, Rhode Island.
authors.forename: Brianna
authors.initials: B
authors.lastname: Bakow
authors.affiliation: From Warren Alpert Medical School of Brown University, Miriam Hospital, and Lifespan Hospital System, Providence, Rhode Island; University of Minnesota, Minneapolis/St. Paul, Minnesota; Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York; and University of Rhode Island, Kingston, Rhode Island.
authors.forename: Patrizia
authors.initials: P
authors.lastname: Curran
authors.affiliation: From Warren Alpert Medical School of Brown University, Miriam Hospital, and Lifespan Hospital System, Providence, Rhode Island; University of Minnesota, Minneapolis/St. Paul, Minnesota; Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York; and University of Rhode Island, Kingston, Rhode Island.
authors.forename: Joyce
authors.initials: J
authors.lastname: McKenney
authors.affiliation: From Warren Alpert Medical School of Brown University, Miriam Hospital, and Lifespan Hospital System, Providence, Rhode Island; University of Minnesota, Minneapolis/St. Paul, Minnesota; Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York; and University of Rhode Island, Kingston, Rhode Island.
authors.forename: Allison
authors.initials: A
authors.lastname: Tisch
authors.affiliation: From Warren Alpert Medical School of Brown University, Miriam Hospital, and Lifespan Hospital System, Providence, Rhode Island; University of Minnesota, Minneapolis/St. Paul, Minnesota; Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York; and University of Rhode Island, Kingston, Rhode Island.
authors.forename: Steven E
authors.initials: SE
authors.lastname: Reinert
authors.affiliation: From Warren Alpert Medical School of Brown University, Miriam Hospital, and Lifespan Hospital System, Providence, Rhode Island; University of Minnesota, Minneapolis/St. Paul, Minnesota; Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York; and University of Rhode Island, Kingston, Rhode Island.
authors.forename: Jason T
authors.initials: JT
authors.lastname: Machan
authors.affiliation: From Warren Alpert Medical School of Brown University, Miriam Hospital, and Lifespan Hospital System, Providence, Rhode Island; University of Minnesota, Minneapolis/St. Paul, Minnesota; Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York; and University of Rhode Island, Kingston, Rhode Island.
authors.forename: Lawrence J
authors.initials: LJ
authors.lastname: Brandt
mesh_terms: D016360:Clostridioides difficile; D003015:Clostridium Infections / Q000382:microbiology / Q000628:therapy*; D003113:Colonoscopy; D003967:Diarrhea / Q000382:microbiology / Q000628:therapy*; D004311:Double-Blind Method; D000069467:Fecal Microbiota Transplantation / Q000009:adverse effects / Q000379:methods; D005260:Female; D006801:Humans; D057194:Intention to Treat Analysis; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012008:Recurrence; D016896:Treatment Outcome