Efficacy of faecal microbiota transplantation for patients with irritable bowel syndrome in a randomised, double-blind, placebo-controlled study
Efficacy of faecal microbiota transplantation for patients with irritable bowel syndrome in a randomised, double-blind, placebo-controlled study
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DOI：
10.1136/gutjnl-2019-319630
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发表时间：
2020-05-01
期刊：
影响因子：
24.5
通讯作者：
Hausken, Trygve
中科院分区：
文献类型：
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作者：
El-Salhy, Magdy;Hatlebakk, Jan Gunnar;Hausken, Trygve
目的在之前的两项双盲、安慰剂对照研究中，曾尝试将健康供者的粪便微生物区系移植给肠易激综合征(IBS)患者。其中一项研究发现IBS症状有所改善，而另一项研究则没有发现任何效果。本研究旨在澄清这些相互矛盾的发现。设计这项随机、双盲、安慰剂对照研究，将165名IBS患者随机分为安慰剂(自己的粪便)、30g FMT或60g FMT，比例为1：1：1。FMT的材料来自一名健康、特征良好的供者，冷冻并通过胃镜给药。主要结果是FMT后3个月IBS症状减轻(有效)。应答被定义为IBS症状总分降低50分或更多。术后1个月，16S rRNA基因测序结果显示，肠道菌群异常指数(DI)下降，肠道细菌谱发生改变。
Objective Faecal microbiota transplantation (FMT) from healthy donors to patients with irritable bowel syndrome (IBS) has been attempted in two previous double-blind, placebo-controlled studies. While one of those studies found improvement of the IBS symptoms, the other found no effect. The present study was conducted to clarify these contradictory findings.Design This randomised, double-blind, placebo-controlled study randomised 165 patients with IBS to placebo (own faeces), 30 g FMT or 60 g FMT at a ratio of 1:1:1. The material for FMT was obtained from one healthy, well-characterised donor, frozen and administered via gastroscope. The primary outcome was a reduction in the IBS symptoms at 3 months after FMT (response). A response was defined as a decrease of 50 or more points in the total IBS symptom score. The secondary outcome was a reduction in the dysbiosis index (DI) and a change in the intestinal bacterial profile, analysed by 16S rRNA gene sequencing, at 1 month following FMT.Results Responses occurred in 23.6%, 76.9% (p