Gastrounit, Medical Division, Copenhagen University Hospital Hvidovre, Copenhagen, Denmark.
Department of Gastroenterology, Aleris-Hamlet Hospitals Copenhagen, Soborg, Denmark.
Scand J Gastroenterol. 2021 Jul;56(7):761-769. doi: 10.1080/00365521.2021.1915375. Epub 2021 May 17.
BACKGROUND: Irritable bowel syndrome (IBS) is associated with intestinal dysbiosis. Therefore, faecal microbiota transplantation (FMT) has been hypothesised to have a positive effect in patients with IBS. In this study, we analysed previously unexamined data from our randomised, double-blind, placebo-controlled study (trial registration number NCT02788071). The objective was to evaluate the effect of FMT on abdominal pain, stool frequency, and stool form. METHOD: The study included 52 adult patients with moderate-to-severe IBS assigned randomly to treatment with FMT capsules or placebo capsules (1:1) for 12 days. The patients were followed for a total of six months, during which they kept a daily symptom diary tracking their abdominal pain on a scale from 0-10 and their bowel movements using the Bristol Stool Form Scale (BSFS). Diary data were not collected before treatment start. RESULTS: A statistically significant improvement in stool frequency was found in the FMT group from during treatment to post-treatment and 1 month. No statistically significant differences were found between groups at any time during the study for any of abdominal pain, stool frequency, and stool form (as measured by weighted stool score). CONCLUSION: In this analysis of results from a randomised, double-blind, placebo-controlled study, we found no clinically beneficial effect of FMT on abdominal pain, stool frequency, or stool form. However, since the current literature on the potential role of FMT in treating IBS shows conflicting results, further studies are required. To assess treatment efficacy, we recommend future studies to include daily symptom diaries both before and after treatment intervention.
背景:肠易激综合征(IBS)与肠道菌群失调有关。因此,粪菌移植(FMT)被假设对 IBS 患者有积极作用。在这项研究中,我们分析了我们之前进行的一项随机、双盲、安慰剂对照研究(试验注册号:NCT02788071)中尚未检查的数据。目的是评估 FMT 对腹痛、排便频率和粪便形状的影响。
方法:该研究纳入了 52 名患有中重度 IBS 的成年患者,他们被随机分为 FMT 胶囊治疗组或安慰剂胶囊治疗组(1:1),治疗时间为 12 天。患者总共随访了 6 个月,在此期间他们每天记录腹痛程度(0-10 分)和排便情况(使用布里斯托粪便形状量表,BSFS)。治疗开始前不收集日记数据。
结果:在 FMT 组中,从治疗期间到治疗后和 1 个月时,排便频率有统计学显著改善。在研究期间的任何时间,两组在腹痛、排便频率和粪便形状(通过加权粪便评分测量)方面均无统计学显著差异。
结论:在这项随机、双盲、安慰剂对照研究结果的分析中,我们没有发现 FMT 对腹痛、排便频率或粪便形状有临床有益的作用。然而,由于目前关于 FMT 在治疗 IBS 方面的潜在作用的文献结果存在冲突,因此需要进一步的研究。为了评估治疗效果,我们建议未来的研究在治疗干预前后都包括每日症状日记。
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