Does Fibre-fix provided to people with irritable bowel syndrome who are consuming a low FODMAP diet improve their gut health, gut microbiome, sleep and mental health? A double-blinded, randomised controlled trial.
Study Goal
The researchers aimed to determine whether adding Fibre-fix to a low-FODMAP diet could improve gut microbiome composition, fermentative capacity, sleep, quality of life, and mental health in IBS patients.
Results Summary
The abstract does not provide specific results, as the study is proposed but not yet completed. The outcomes will assess changes in gut health, sleep, mental well-being, and symptom exacerbation.
Population
Patients with irritable bowel syndrome (IBS) following a low-FODMAP diet.
Effective Dosage
Not specified
Duration
3-week intervention
Interactions
None mentioned
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
a diet low in fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAP) | decrease | gut symptoms | people with irritable bowel syndrome (IBS) | - | is an effective way to reduce | #1 |
a diet low in fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAP) | decrease | the intake of fermentable fibres | people with irritable bowel syndrome (IBS) | - | reduces | #2 |
a diet low in fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAP) | neutral | the gut microbiota | people with irritable bowel syndrome (IBS) | - | leading to changes of | #3 |
a diet low in fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAP) | decrease | short-chain fatty acids (SCFAs), such as butyrate | people with irritable bowel syndrome (IBS) | - | resulting in reduced production of | #4 |
Fibre-fix, a supplement containing a mix of dietary fibres | neutral | the human gut microbiome composition, fermentative capacity, sleep, quality of life (QOL) and mental health | people with IBS who consume a low FODMAP diet (LFD) | - | will examine the effect of | #5 |
Fibre-fix added to an existing LFD | neutral | gastrointestinal function | patients with IBS | - | may help modulate | #6 |
Fibre-fix added to an existing LFD | increase | sleep, mental health | patients with IBS | - | improve markers of | #7 |
Fibre-fix added to an existing LFD | increase | QOL | patients with IBS | - | promote | #8 |
Fibre-fix | increase | gut microbial composition, SCFA production, sleep and mental well-being | those with IBS following an LFD | - | is shown to result in favourable changes in | #9 |
Fibre-fix | no change | symptoms | those with IBS following an LFD | - | without exacerbating | #10 |
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.