Fecal Microbiota Transplantation Induces Remission in Patients With Active Ulcerative Colitis in a Randomized Controlled Trial
Fecal Microbiota Transplantation Induces Remission in Patients With Active Ulcerative Colitis in a Randomized Controlled Trial
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DOI：
10.1053/j.gastro.2015.04.001
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发表时间：
2015-07-01
期刊：
影响因子：
29.4
通讯作者：
Lee, Christine H.
中科院分区：
文献类型：
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作者：
Moayyedi, Paul;Surette, Michael G.;Lee, Christine H.
背景与目的：溃疡性结肠炎（UC）很难治疗，标准治疗并不总能缓解。粪便微生物群移植（FMT）是一种替代方法，可在小系列活动性UC患者中诱导缓解。我们在安慰剂对照随机试验中研究了其安全性和有效性。方法：我们对无感染性腹泻的活动性UC患者进行了平行研究。参与者在研究开始时接受了乙状结肠镜检查，然后被随机分配到接受FMT（50 mL，通过灌肠，来自健康匿名捐赠者; n = 38）或安慰剂（50 mL水灌肠; n = 37）的组，每周一次，持续6周。患者、临床医生和研究者对这些组不知情。主要结局是UC缓解，定义为马约评分
BACKGROUND & AIMS: 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