School of Medical and Health Sciences, Edith Cowan University, Joondalup, Western Australia, Australia
School of Medical and Health Sciences, Edith Cowan University, Joondalup, Western Australia, Australia.
BMJ Open Gastroenterol. 2020 Aug;7(1). doi: 10.1136/bmjgast-2020-000448.
INTRODUCTION: A diet low in fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAP) is an effective way to reduce gut symptoms in people with irritable bowel syndrome (IBS). This diet reduces the intake of fermentable fibres, leading to changes of the gut microbiota and insufficient fermentation in the large bowel, resulting in reduced production of short-chain fatty acids (SCFAs), such as butyrate, which has unfavourable implications for gut health, sleep and mental health. This study will examine the effect of Fibre-fix, a supplement containing a mix of dietary fibres, on the human gut microbiome composition, fermentative capacity, sleep, quality of life (QOL) and mental health of people with IBS who consume a low FODMAP diet (LFD). METHODS AND ANALYSIS: A randomised, double-blind, placebo-controlled, study design is proposed to examine whether Fibre-fix added to an existing LFD may help modulate gastrointestinal function, improve markers of sleep, mental health and promote QOL in patients with IBS. Participants will provide stool and blood samples, daily bowel symptoms diaries and 3-day diet records. Additionally, they will complete validated questionnaires relating to FODMAP intake, sleep, mental health and QOL before and after a 3-week intervention. Gut health will be assessed via faecal microbiome composition, faecal pH and SCFA levels. Alteration of sleep will be recorded using an actigraphy device worn by all participants over the whole study. Multivariate analysis will be used to examine the gut microbiome and repeated measures Analysis of variance (ANOVA) will be used for dependent variables from questionnaires related to bowel symptoms, stool type, sleep, mental health and QOL to assess the differences between intervention and control groups after adjustment for confounding variables. ETHICS AND DISSEMINATION: Ethics approval was obtained from the Human Research Ethics Committee of Edith Cowan University (2019-00619-YAN). Results will be disseminated in peer-review journal publications, and conference presentations. Participants will be provided with a summary of findings once the study is completed. If Fibre-fix is shown to result in favourable changes in gut microbial composition, SCFA production, sleep and mental well-being without exacerbating symptoms, this will provide additional dietary management options for those with IBS following an LFD. TRIAL REGISTRATION NUMBER: ACTRN12620000032954.
简介:低可发酵寡糖、双糖、单糖和多元醇(FODMAP)饮食是减轻肠易激综合征(IBS)患者肠道症状的有效方法。这种饮食减少了可发酵纤维的摄入,导致肠道微生物群的变化和大肠中发酵不足,从而导致短链脂肪酸(SCFA)的产生减少,如丁酸,这对肠道健康、睡眠和心理健康都有不利影响。本研究将探讨 Fibre-fix(一种含有混合膳食纤维的补充剂)对摄入低 FODMAP 饮食(LFD)的 IBS 患者的肠道微生物组组成、发酵能力、睡眠、生活质量(QOL)和心理健康的影响。
方法和分析:拟采用随机、双盲、安慰剂对照的研究设计,研究 Fibre-fix 添加到现有的 LFD 是否有助于调节胃肠道功能,改善睡眠、心理健康标志物,并促进 IBS 患者的 QOL。参与者将提供粪便和血液样本、每日肠道症状日记和 3 天饮食记录。此外,他们将在 3 周干预前后完成与 FODMAP 摄入、睡眠、心理健康和 QOL 相关的验证问卷。肠道健康将通过粪便微生物组组成、粪便 pH 值和 SCFA 水平进行评估。使用所有参与者佩戴的活动记录仪记录睡眠变化。多变量分析将用于检查肠道微生物组,重复测量方差分析(ANOVA)将用于与肠道症状、粪便类型、睡眠、心理健康和 QOL 相关的问卷的因变量,以在调整混杂变量后评估干预组和对照组之间的差异。
伦理和传播:伊迪丝·考恩大学人类研究伦理委员会已批准(2019-00619-YAN)。研究结果将在同行评审期刊上发表,并在会议上展示。研究完成后,将向参与者提供研究结果摘要。如果 Fibre-fix 显示出在不加重症状的情况下,对肠道微生物组成、SCFA 产生、睡眠和心理健康产生有利的变化,那么这将为遵循 LFD 的 IBS 患者提供额外的饮食管理选择。
试验注册编号:ACTRN12620000032954。
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