Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong SAR, China.
Microbiota I-Center (MagIC), Hong Kong SAR, China.
Aliment Pharmacol Ther. 2023 Oct;58(8):795-804. doi: 10.1111/apt.17703. Epub 2023 Sep 5.
BACKGROUND: Faecal microbiota transplantation (FMT) has been shown to improve symptoms in a proportion of patients with irritable bowel syndrome (IBS). AIM: We performed a randomised trial to assess the efficacy of FMT in patients with IBS. METHODS: We randomised 56 patients with diarrhoea-predominant IBS 1:1 to FMT or placebo via the duodenal route at baseline and week 4. The primary outcome was > 50 points decrease in IBS severity scoring system (IBS-SSS) score at week 12. Secondary outcomes were improvement in bloating and change in gut microbiota at week 12. After 12-week follow-up, those in the placebo group were assigned to receive open-label FMT. RESULTS: At week 12, 57.1% in the FMT group and 46.4% in the placebo group achieved the primary endpoint (p = 0.42). More patients receiving FMT than placebo had improvement in bloating (72% vs 30%; p = 0.005). In an open-label extension, 65.2% and 82.4% of patients achieved, respectively, the primary endpoint and improvement in bloating. Faecal microbiome of patients in the FMT group showed a reduction in bacteria like Ruminococcus gnavus and enrichment of bacteria such as Lawsonibacter at week 12, while no change in the placebo group. Functional analyses showed that the hydrogen sulphide-producing pathway decreased in patients who had FMT (p < 0.05) accompanied by a reduction in contributing bacteria. There were no serious adverse events related to FMT. CONCLUSION: FMT performed twice at an interval of four weeks did not significantly reduce IBS-SSS score. However, more patients had improvement in abdominal bloating, which was associated with a reduction in hydrogen sulphide-producing bacteria. (ClinicalTrials.gov NCT03125564).
背景:粪便微生物群移植(FMT)已被证明可改善一部分肠易激综合征(IBS)患者的症状。
目的:我们进行了一项随机试验,以评估 FMT 在 IBS 患者中的疗效。
方法:我们将 56 例腹泻型 IBS 患者按 1:1 比例随机分为 FMT 组或安慰剂组,于基线和第 4 周经十二指肠途径给药。主要终点为第 12 周时 IBS 严重程度评分系统(IBS-SSS)评分下降>50 分。次要终点为第 12 周时腹胀改善和肠道微生物群变化。12 周随访后,安慰剂组患者接受开放标签 FMT。
结果:第 12 周时,FMT 组和安慰剂组分别有 57.1%和 46.4%的患者达到主要终点(p=0.42)。接受 FMT 的患者比安慰剂组患者腹胀改善的比例更高(72%比 30%;p=0.005)。在开放标签扩展研究中,分别有 65.2%和 82.4%的患者达到主要终点和腹胀改善。FMT 组患者的粪便微生物组在第 12 周时显示出像 Ruminococcus gnavus 这样的细菌减少和 Lawsonibacter 等细菌富集,而安慰剂组没有变化。功能分析显示,接受 FMT 的患者体内产生硫化氢的途径减少(p<0.05),同时相关细菌减少。FMT 无相关严重不良事件。
结论:相隔四周进行两次 FMT 并未显著降低 IBS-SSS 评分。然而,更多的患者腹胀得到改善,这与硫化氢产生细菌减少有关。(ClinicalTrials.gov NCT03125564)。
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