在一项随机、双盲、安慰剂对照研究中评估粪便微生物群移植治疗肠易激综合征患者的疗效。

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<0.0001) and 89.1% (p<00.0001) of the patients who received placebo, 30 g FMT and 60 g FMT, respectively. These were accompanied by significant improvements in fatigue and the quality of life in patients who received FMT. The intestinal bacterial profiles changed also significantly in the groups received FMT. The FMT adverse events were mild self-limiting gastrointestinal symptoms. CONCLUSIONS: FMT is an effective treatment for patients with IBS. Utilising a well-defined donor with a normal DI and favourable specific microbial signature is essential for successful FMT. The response to FMT increases with the dose. www.clinicaltrials.gov (NCT03822299) and www.cristin.no (ID657402).

目的：已有两项双盲、安慰剂对照研究尝试使用健康供体的粪便微生物群移植（FMT）治疗肠易激综合征（IBS）患者。其中一项研究发现 IBS 症状得到改善，而另一项研究则未发现效果。本研究旨在阐明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 例 IBS 患者随机分为安慰剂（自身粪便）组、30g FMT 组或 60g FMT 组（1:1:1）。FMT 的材料取自一位健康、特征明确的供体，冷冻后通过胃镜给予。主要结局是 FMT 后 3 个月 IBS 症状的减少（应答）。应答定义为总 IBS 症状评分减少 50 分或更多。次要结局是 1 个月时肠道细菌谱的变化，用 16S rRNA 基因测序分析，分析菌群失调指数（DI）和肠道细菌谱的变化。

结果：接受安慰剂、30g FMT 和 60g FMT 的患者应答率分别为 23.6%、76.9%（p<0.0001）和 89.1%（p<0.0001）。FMT 还显著改善了患者的疲劳和生活质量。接受 FMT 的患者肠道细菌谱也发生了显著变化。FMT 的不良反应是轻微的自限性胃肠道症状。

结论：FMT 是 IBS 患者的有效治疗方法。使用 DI 正常且具有有利特定微生物特征的明确供体对于成功进行 FMT 至关重要。FMT 的应答率随剂量增加而增加。www.clinicaltrials.gov（NCT03822299）和 www.cristin.no（ID657402）。