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https://hdl.handle.net/2440/117865
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dc.contributor.author | Costello, S.P. | - |
dc.contributor.author | Hughes, P.A. | - |
dc.contributor.author | Waters, O. | - |
dc.contributor.author | Bryant, R.V. | - |
dc.contributor.author | Vincent, A.D. | - |
dc.contributor.author | Blatchford, P. | - |
dc.contributor.author | Katsikeros, R. | - |
dc.contributor.author | Makanyanga, J. | - |
dc.contributor.author | Campaniello, M.A. | - |
dc.contributor.author | Mavrangelos, C. | - |
dc.contributor.author | Rosewarne, C.P. | - |
dc.contributor.author | Bickley, C. | - |
dc.contributor.author | Peters, C. | - |
dc.contributor.author | Schoeman, M.N. | - |
dc.contributor.author | Conlon, M.A. | - |
dc.contributor.author | Roberts-Thomson, I.C. | - |
dc.contributor.author | Andrews, J.M. | - |
dc.date.issued | 2019 | - |
dc.identifier.citation | JAMA: Journal of the American Medical Association, 2019; 321(2):156-164 | - |
dc.identifier.issn | 0098-7484 | - |
dc.identifier.issn | 1538-3598 | - |
dc.identifier.uri | http://hdl.handle.net/2440/117865 | - |
dc.description.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. | - |
dc.description.statementofresponsibility | Jane M. Andrews … Robert V. (Rob) Bryant … Samuel P. Costello … Patrick A. Hughes … Ian C. Roberts-Thomson … Andrew D. Vincent … et al. | - |
dc.language.iso | en | - |
dc.publisher | American Medical Association | - |
dc.rights | © 2019 American Medical Association. All rights reserved. | - |
dc.source.uri | http://dx.doi.org/10.1001/jama.2018.20046 | - |
dc.subject | Humans | - |
dc.subject | Colitis, Ulcerative | - |
dc.subject | Colonoscopy | - |
dc.subject | Enema | - |
dc.subject | Remission Induction | - |
dc.subject | Transplantation, Autologous | - |
dc.subject | Transplantation, Homologous | - |
dc.subject | Double-Blind Method | - |
dc.subject | Anaerobiosis | - |
dc.subject | Adult | - |
dc.subject | Middle Aged | - |
dc.subject | Female | - |
dc.subject | Male | - |
dc.subject | Metabolome | - |
dc.subject | Young Adult | - |
dc.subject | Surveys and Questionnaires | - |
dc.subject | Gastrointestinal Microbiome | - |
dc.subject | Fecal Microbiota Transplantation | - |
dc.title | Effect of fecal microbiota transplantation on 8-week remission in patients with ulcerative colitis: a randomized clinical trial | - |
dc.type | Journal article | - |
dc.identifier.doi | 10.1001/jama.2018.20046 | - |
dc.relation.grant | NHMRC | - |
pubs.publication-status | Published | - |
dc.identifier.orcid | Costello, S.P. [0000-0002-2857-1812] | - |
dc.identifier.orcid | Hughes, P.A. [0000-0001-7324-3626] | - |
dc.identifier.orcid | Bryant, R.V. [0000-0003-4229-3289] | - |
dc.identifier.orcid | Vincent, A.D. [0000-0002-6428-1070] | - |
dc.identifier.orcid | Roberts-Thomson, I.C. [0000-0001-6075-3643] | - |
dc.identifier.orcid | Andrews, J.M. [0000-0001-7960-2650] | - |
Appears in Collections: | Aurora harvest 3 Medicine publications |
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