title: Findings From a Randomized Controlled Trial of Fecal Transplantation for Patients With Ulcerative Colitis.
abstract: OBJECTIVE
  Several case series have reported the effects of fecal microbiota transplantation (FMT) for ulcerative colitis (UC). We assessed the efficacy and safety of FMT for patients with UC in a double-blind randomized trial.
  
  
  METHODS
  Patients with mild to moderately active UC (n = 50) were assigned to groups that underwent FMT with feces from healthy donors or were given autologous fecal microbiota (control); each transplant was administered via nasoduodenal tube at the start of the study and 3 weeks later. The study was performed at the Academic Medical Center in Amsterdam from June 2011 through May 2014. The composite primary end point was clinical remission (simple clinical colitis activity index scores ≤2) combined with ≥1-point decrease in the Mayo endoscopic score at week 12. Secondary end points were safety and microbiota composition by phylogenetic microarray in fecal samples.
  
  
  RESULTS
  Thirty-seven patients completed the primary end point assessment. In the intention-to-treat analysis, 7 of 23 patients who received fecal transplants from healthy donors (30.4%) and 5 of 25 controls (20.0%) achieved the primary end point (P = .51). In the per-protocol analysis, 7 of 17 patients who received fecal transplants from healthy donors (41.2%) and 5 of 20 controls (25.0%) achieved the primary end point (P = .29). Serious adverse events occurred in 4 patients (2 in the FMT group), but these were not considered to be related to the FMT. At 12 weeks, the microbiota of responders in the FMT group was similar to that of their healthy donors; remission was associated with proportions of Clostridium clusters IV and XIVa.
  
  
  CONCLUSIONS
  In this phase 2 trial, there was no statistically significant difference in clinical and endoscopic remission between patients with UC who received fecal transplants from healthy donors and those who received their own fecal microbiota, which may be due to limited numbers. However, the microbiota of responders had distinct features from that of nonresponders, warranting further study. ClinicalTrials.gov Number: NCT01650038.
authors.affiliation: Department of Gastroenterology and Hepatology, Academic Medical Center, Amsterdam, The Netherlands.
authors.forename: Noortje G
authors.initials: NG
authors.lastname: Rossen
authors.affiliation: Laboratory of Microbiology, Wageningen University, Wageningen, The Netherlands.
authors.forename: Susana
authors.initials: S
authors.lastname: Fuentes
authors.affiliation: Department of Gastroenterology and Hepatology, Academic Medical Center, Amsterdam, The Netherlands.
authors.forename: Mirjam J
authors.initials: MJ
authors.lastname: van der Spek
authors.affiliation: Department of Cardiology, Academic Medical Center, Amsterdam, The Netherlands.
authors.forename: Jan G
authors.initials: JG
authors.lastname: Tijssen
authors.affiliation: Laboratory of Microbiology, Wageningen University, Wageningen, The Netherlands.
authors.forename: Jorn H A
authors.initials: JH
authors.lastname: Hartman
authors.affiliation: Department of Gastroenterology and Hepatology, Academic Medical Center, Amsterdam, The Netherlands.
authors.forename: Ann
authors.initials: A
authors.lastname: Duflou
authors.affiliation: Department of Gastroenterology and Hepatology, Academic Medical Center, Amsterdam, The Netherlands.
authors.forename: Mark
authors.initials: M
authors.lastname: Löwenberg
authors.affiliation: Department of Gastroenterology and Hepatology, Academic Medical Center, Amsterdam, The Netherlands.
authors.forename: Gijs R
authors.initials: GR
authors.lastname: van den Brink
authors.affiliation: Department of Gastroenterology and Hepatology, Academic Medical Center, Amsterdam, The Netherlands.
authors.forename: Elisabeth M H
authors.initials: EM
authors.lastname: Mathus-Vliegen
authors.affiliation: Laboratory of Microbiology, Wageningen University, Wageningen, The Netherlands; Departments of Bacteriology and Immunology and Veterinary Biosciences, University of Helsinki, Finland.
authors.forename: Willem M
authors.initials: WM
authors.lastname: de Vos
authors.affiliation: Laboratory of Microbiology, Wageningen University, Wageningen, The Netherlands.
authors.forename: Erwin G
authors.initials: EG
authors.lastname: Zoetendal
authors.affiliation: Department of Gastroenterology and Hepatology, Academic Medical Center, Amsterdam, The Netherlands.
authors.forename: Geert R
authors.initials: GR
authors.lastname: D'Haens
authors.affiliation: Department of Gastroenterology and Hepatology, Academic Medical Center, Amsterdam, The Netherlands. Electronic address: c.y.ponsioen@amc.nl.
authors.forename: Cyriel Y
authors.initials: CY
authors.lastname: Ponsioen
mesh_terms: D000328:Adult; D000368:Aged; D001691:Biological Therapy / Q000379:methods*; D003093:Colitis, Ulcerative / Q000628:therapy*; D004311:Double-Blind Method; D005243:Feces / Q000382:microbiology*; D005260:Female; D006801:Humans; D007441:Intubation, Gastrointestinal / Q000706:statistics & numerical data; D008297:Male; D064307:Microbiota; D008875:Middle Aged; D012074:Remission Induction; D016896:Treatment Outcome
keywords: Fecal Microbiota Transplantation; Inflammatory Bowel Disease; Randomized Controlled Trial