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. Trial registration www.clinicaltrials.gov (NCT03822299) and www.cristin.no (ID657402).

中文翻译：

---

一项随机、双盲、安慰剂对照研究中粪便微生物群移植对肠易激综合征患者的疗效

目的 在之前的两项双盲、安慰剂对照研究中，已经尝试将健康供体的粪便微生物群移植 (FMT) 移植到肠易激综合征 (IBS) 患者。虽然其中一项研究发现 IBS 症状有所改善，但另一项研究发现没有效果。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 患者随机分配至安慰剂（自己的粪便）、30 g FMT 或 60 g FMT，比例为 1:1:1。FMT 的材料来自一位健康、特征明确的供体，冷冻并通过胃镜给药。主要结果是 FMT 后 3 个月 IBS 症状的减轻（反应）。反应定义为 IBS 症状总分下降 50 分或更多。次要结果是在 FMT 后 1 个月，通过 16S rRNA 基因测序分析，生态失调指数 (DI) 降低和肠道细菌谱发生变化。结果 在接受安慰剂、30 g FMT 和 60 g FMT 的患者中，分别有 23.6%、76.9% (p<0.0001) 和 89.1% (p<00.0001) 的反应发生。这些伴随着接受 FMT 的患者的疲劳和生活质量的显着改善。在接受 FMT 的组中，肠道细菌谱也发生了显着变化。FMT 不良事件为轻度自限性胃肠道症状。结论 FMT是IBS患者的有效治疗方法。利用具有正常 DI 和有利的特定微生物特征的明确供体对于成功的 FMT 至关重要。对 FMT 的反应随着剂量的增加而增加。