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粪便微生物群移植改变肠易激综合征患者的肠道微生物群:一项随机、双盲、安慰剂对照研究的结果。

Faecal microbiota transplantation alters gut microbiota in patients with irritable bowel syndrome: results from a randomised, double-blind placebo-controlled study.

机构信息

Department of Gastroenterology, Copenhagen University Hospital Hvidovre, Copenhagen, Denmark.

Department of Gastroenterology, Aleris-Hamlet Hospitals Copenhagen, Soborg, Denmark.

出版信息

Gut. 2018 Dec;67(12):2107-2115. doi: 10.1136/gutjnl-2018-316434. Epub 2018 Jul 6.

DOI:10.1136/gutjnl-2018-316434
PMID:29980607
Abstract

OBJECTIVE

IBS is associated with an intestinal dysbiosis and faecal microbiota transplantation (FMT) has been hypothesised to have a positive effect in patients with IBS. We performed a randomised, double-blind placebo-controlled trial to investigate if FMT resulted in an altered gut microbiota and improvement in clinical outcome in patients with IBS.

DESIGN

We performed this study in 52 adult patients with moderate-to-severe IBS. At the screening visit, clinical history and symptoms were assessed and faecal samples were collected. Patients were randomised to FMT or placebo capsules for 12 days and followed for 6 months. Study visits were performed at baseline, 1, 3 and 6 months, where patients were asked to register their symptoms using the IBS-severity scoring system (IBS-SSS) and IBS-specific quality of life (IBS-QoL). Prior to each visit, faecal samples were collected.

RESULTS

A significant difference in improvement in IBS-SSS score was observed 3 months after treatment (p=0.012) favouring placebo. This was similar for IBS-QoL data after 3 months (p=0.003) favouring placebo. Patients receiving FMT capsules had an increase in faecal microbial biodiversity while placebos did not.

CONCLUSION

In this randomised double-blinded placebo-controlled study, we found that FMT changed gut microbiota in patients with IBS. But patients in the placebo group experienced greater symptom relief compared with the FMT group after 3 months. Altering the gut microbiota is not enough to obtain clinical improvement in IBS. However, different study designs and larger studies are required to examine the role of FMT in IBS.

TRIAL REGISTRATION NUMBER

NCT02788071.

摘要

目的

IBS 与肠道菌群失调有关,粪便微生物群移植(FMT)被认为对 IBS 患者有积极作用。我们进行了一项随机、双盲、安慰剂对照试验,以研究 FMT 是否会改变肠道微生物群,并改善 IBS 患者的临床结局。

设计

我们在 52 名患有中重度 IBS 的成年患者中进行了这项研究。在筛选就诊时,评估了临床病史和症状,并收集了粪便样本。患者被随机分配接受 FMT 或安慰剂胶囊治疗 12 天,并随访 6 个月。在基线、1、3 和 6 个月进行研究就诊,在此期间,患者使用 IBS 严重程度评分系统(IBS-SSS)和 IBS 特异性生活质量(IBS-QoL)登记他们的症状。在每次就诊前收集粪便样本。

结果

治疗 3 个月后,IBS-SSS 评分的改善有显著差异(p=0.012),安慰剂组更有利。3 个月后 IBS-QoL 数据也类似(p=0.003),安慰剂组更有利。接受 FMT 胶囊的患者粪便微生物多样性增加,而安慰剂组则没有。

结论

在这项随机、双盲、安慰剂对照研究中,我们发现 FMT 改变了 IBS 患者的肠道微生物群。但在 3 个月后,接受安慰剂组的患者比接受 FMT 组的患者症状缓解更明显。改变肠道微生物群不足以获得 IBS 的临床改善。然而,需要不同的研究设计和更大的研究来检验 FMT 在 IBS 中的作用。

试验注册号

NCT02788071。

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