title: Fecal Microbiota Transplantation Induces Remission in Patients With Active Ulcerative Colitis in a Randomized Controlled Trial.
abstract: OBJECTIVE
  Ulcerative colitis (UC) is difficult to treat, and standard therapy does not always induce remission. Fecal microbiota transplantation (FMT) is an alternative approach that induced remission in small series of patients with active UC. We investigated its safety and efficacy in a placebo-controlled randomized trial.
  
  
  METHODS
  We performed a parallel study of patients with active UC without infectious diarrhea. Participants were examined by flexible sigmoidoscopy when the study began and then were randomly assigned to groups that received FMT (50 mL, via enema, from healthy anonymous donors; n = 38) or placebo (50 mL water enema; n = 37) once weekly for 6 weeks. Patients, clinicians, and investigators were blinded to the groups. The primary outcome was remission of UC, defined as a Mayo score ≤2 with an endoscopic Mayo score of 0, at week 7. Patients provided stool samples when the study began and during each week of FMT for microbiome analysis. The trial was stopped early for futility by the Data Monitoring and Safety Committee, but all patients already enrolled in the trial were allowed to complete the study.
  
  
  RESULTS
  Seventy patients completed the trial (3 dropped out from the placebo group and 2 from the FMT group). Nine patients who received FMT (24%) and 2 who received placebo (5%) were in remission at 7 weeks (a statistically significant difference in risk of 17%; 95% confidence interval, 2%-33%). There was no significant difference in adverse events between groups. Seven of the 9 patients in remission after FMT received fecal material from a single donor. Three of the 4 patients with UC ≤1 year entered remission, compared with 6 of 34 of those with UC >1 year (P = .04, Fisher's exact test). Stool from patients receiving FMT had greater microbial diversity, compared with baseline, than that of patients given the placebo (P = .02, Mann-Whitney U test).
  
  
  CONCLUSIONS
  FMT induces remission in a significantly greater percentage of patients with active UC than placebo, with no difference in adverse events. Fecal donor and time of UC appear to affect outcomes. ClinicalTrials.gov Number: NCT01545908.
authors: Farncombe Family Digestive Health Research Institute, Department of Medicine, McMaster University, Hamilton, Ontario, Canada. Electronic address: moayyep@mcmaster.ca.
authors: Paul
authors: P
authors: Moayyedi
authors: Farncombe Family Digestive Health Research Institute, Department of Medicine, McMaster University, Hamilton, Ontario, Canada.
authors: Michael G
authors: MG
authors: Surette
authors: Department of Mathematics and Statistics, University of Guelph, Guelph, Ontario, Canada; Department of Pathology and Molecular Medicine, St Joseph's Healthcare, McMaster University, Hamilton, Ontario, Canada.
authors: Peter T
authors: PT
authors: Kim
authors: Farncombe Family Digestive Health Research Institute, Department of Medicine, McMaster University, Hamilton, Ontario, Canada.
authors: Josie
authors: J
authors: Libertucci
authors: Farncombe Family Digestive Health Research Institute, Department of Medicine, McMaster University, Hamilton, Ontario, Canada.
authors: Melanie
authors: M
authors: Wolfe
authors: Department of Pathology and Molecular Medicine, St Joseph's Healthcare, McMaster University, Hamilton, Ontario, Canada.
authors: Catherine
authors: C
authors: Onischi
authors: Farncombe Family Digestive Health Research Institute, Department of Medicine, McMaster University, Hamilton, Ontario, Canada.
authors: David
authors: D
authors: Armstrong
authors: Farncombe Family Digestive Health Research Institute, Department of Medicine, McMaster University, Hamilton, Ontario, Canada.
authors: John K
authors: JK
authors: Marshall
authors: Department of Biological Engineering, Massachusetts Institute of Technology, Cambridge, Massachusetts.
authors: Zain
authors: Z
authors: Kassam
authors: Farncombe Family Digestive Health Research Institute, Department of Medicine, McMaster University, Hamilton, Ontario, Canada.
authors: Walter
authors: W
authors: Reinisch
authors: Department of Pathology and Molecular Medicine, St Joseph's Healthcare, McMaster University, Hamilton, Ontario, Canada.
authors: Christine H
authors: CH
authors: Lee
mesh_terms: D000328:Adult; D000368:Aged; D001691:Biological Therapy / Q000379:methods*; D003093:Colitis, Ulcerative / Q000503:physiopathology / Q000628:therapy*; D005243:Feces / Q000382:microbiology*; D005260:Female; D006801:Humans; D008297:Male; D064307:Microbiota; D008875:Middle Aged; D012074:Remission Induction
keywords: Colon; IBD; Microbe; Treatment