Multidonor intensive faecal microbiota transplantation for active ulcerative colitis: a randomised placebo-controlled trial
Multidonor intensive faecal microbiota transplantation for active ulcerative colitis: a randomised placebo-controlled trial
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DOI：
10.1016/s0140-6736(17)30182-4
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发表时间：
2017-03-25
期刊：
影响因子：
168.9
通讯作者：
Borody, Thomas J.
中科院分区：
文献类型：
--
作者：
Paramsothy, Sudarshan;Kamm, Michael A.;Borody, Thomas J.
背景肠道菌群参与溃疡性结肠炎的发病机制。粪便微生物群移植是一种新型的治疗性微生物操作，但其在溃疡性结肠炎中的疗效尚不确定。我们的目的是建立密集给药，多供体，粪便微生物群移植在活动性溃疡性colitis.Methods的疗效，我们进行了多中心，双盲，随机，安慰剂对照试验在澳大利亚的三家医院。我们使用预先建立的随机化列表，将患有活动性溃疡性结肠炎（马约评分4-10）的患者以1：1的比例随机分配至粪便微生物群移植或安慰剂结肠镜输注，然后每周灌肠5天，持续8周。患者、治疗临床医生和其他研究工作人员不知道分配的治疗。粪便微生物群移植灌肠剂各自来自3至7个无关供体。主要转归是无激素临床缓解伴内镜缓解或应答（马约评分
Background The intestinal microbiota is implicated in the pathogenesis of ulcerative colitis. Faecal microbiota transplantation is a novel form of therapeutic microbial manipulation, but its efficacy in ulcerative colitis is uncertain. We aimed to establish the efficacy of intensive-dosing, multidonor, faecal microbiota transplantation in active ulcerative colitis.Methods We conducted a multicentre, double-blind, randomised, placebo-controlled trial at three hospitals in Australia. We randomly allocated patients with active ulcerative colitis (Mayo score 4-10) in a 1: 1 ratio, using a preestablished randomisation list, to either faecal microbiota transplantation or placebo colonoscopic infusion, followed by enemas 5 days per week for 8 weeks. Patients, treating clinicians, and other study staff were unaware of the assigned treatment. Faecal microbiota transplantation enemas were each derived from between three and seven unrelated donors. The primary outcome was steroid-free clinical remission with endoscopic remission or response (Mayo score