Please use this identifier to cite or link to this item: http://hdl.handle.net/2440/117865
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Type: Journal article
Title: Effect of fecal microbiota transplantation on 8-week remission in patients with ulcerative colitis: a randomized clinical trial
Author: Costello, S.
Hughes, P.
Waters, O.
Bryant, R.
Vincent, A.
Blatchford, P.
Katsikeros, R.
Makanyanga, J.
Campaniello, M.
Mavrangelos, C.
Rosewarne, C.
Bickley, C.
Peters, C.
Schoeman, M.
Conlon, M.
Roberts-Thomson, I.
Andrews, J.
Citation: JAMA - Journal of the American Medical Association, 2019; 321(2):156-164
Publisher: American Medical Association
Issue Date: 2019
ISSN: 0098-7484
1538-3598
Statement of
Responsibility: 
Jane M. Andrews … Robert V. (Rob) Bryant … Samuel P. Costello … Patrick A. Hughes … Ian C. Roberts-Thomson … Andrew D. Vincent … et al.
Abstract: Importance: High-intensity, aerobically prepared fecal microbiota transplantation (FMT) has demonstrated efficacy in treating active ulcerative colitis (UC). FMT protocols involving anaerobic stool processing methods may enhance microbial viability and allow efficacy with a lower treatment intensity. Objective: To assess the efficacy of a short duration of FMT therapy to induce remission in UC using anaerobically prepared stool. Design, Setting, and Participants: A total of 73 adults with mild to moderately active UC were enrolled in a multicenter, randomized, double-blind clinical trial in 3 Australian tertiary referral centers between June 2013 and June 2016, with 12-month follow-up until June 2017. Interventions: Patients were randomized to receive either anaerobically prepared pooled donor FMT (n = 38) or autologous FMT (n = 35) via colonoscopy followed by 2 enemas over 7 days. Open-label therapy was offered to autologous FMT participants at 8 weeks and they were followed up for 12 months. Main Outcomes and Measures: The primary outcome was steroid-free remission of UC, defined as a total Mayo score of ≤2 with an endoscopic Mayo score of 1 or less at week 8. Total Mayo score ranges from 0 to 12 (0 = no disease and 12 = most severe disease). Steroid-free remission of UC was reassessed at 12 months. Secondary clinical outcomes included adverse events. Results: Among 73 patients who were randomized (mean age, 39 years; women, 33 [45%]), 69 (95%) completed the trial. The primary outcome was achieved in 12 of the 38 participants (32%) receiving pooled donor FMT compared with 3 of the 35 (9%) receiving autologous FMT (difference, 23% [95% CI, 4%-42%]; odds ratio, 5.0 [95% CI, 1.2-20.1]; P = .03). Five of the 12 participants (42%) who achieved the primary end point at week 8 following donor FMT maintained remission at 12 months. There were 3 serious adverse events in the donor FMT group and 2 in the autologous FMT group. Conclusions and Relevance: In this preliminary study of adults with mild to moderate UC, 1-week treatment with anaerobically prepared donor FMT compared with autologous FMT resulted in a higher likelihood of remission at 8 weeks. Further research is needed to assess longer-term maintenance of remission and safety. Trial Registration: anzctr.org.au Identifier: ACTRN12613000236796.
Keywords: Humans; Colitis, Ulcerative; Colonoscopy; Enema; Remission Induction; Transplantation, Autologous; Transplantation, Homologous; Double-Blind Method; Anaerobiosis; Adult; Middle Aged; Female; Male; Metabolome; Young Adult; Surveys and Questionnaires; Gastrointestinal Microbiome; Fecal Microbiota Transplantation
Rights: © 2019 American Medical Association. All rights reserved.
RMID: 0030106606
DOI: 10.1001/jama.2018.20046
Appears in Collections:Medicine publications

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