None listed
Conditions
Brief summary
This study will examine the effect of Fibre-fix (dietary fibre supplement) on the human gut microbiome and faecal metabolites of people with Irritable Bowel Syndrome (IBS) who consume a diet low in fermentable oligosaccharide, disaccharides, monosaccharides and polyols (FODMAP). A low FODMAP diet reduces the intake of fermentable fibres, leading to insufficient fermentation by the gut microbiota. This can thereby reduce the production of short chain fatty acids (SCFA, e.g. butyrate) in the large intestine and influence on modulation of sleep and mental health. A randomized double-blind placebo controlled study design is proposed to examine whether Fibre-fix supplement, added to an existing low FODMAP diet may help modulate gastrointestinal function, improve markers of sleep and mental health and promote increased quality of life in IBS patients. Participants will provide stool samples, and complete questionnaires about sleep and mental health before and after the 3-week intervention. Gut health biomarkers: faecal microbiome composition, faecal pH and butyrate levels, and alteration of sleep and mental conditions will be examined. A repeated measures ANOVA using the Statistical Package for the Social Sciences (SPSS) version 25.0 will be used to assess the differences between groups after adjustment for confounding variables. We expect a shift in the diversity of the microbiota and associated increase in the butyrate levels and improvement in general mental health and sleep in those who receive Fibre -fix compared to those who receive control. In addition, the benefits of RS are likely to reduce IBS symptoms and improve gut health whilst on a low FODMAP diet, proposing a long-term dietary solution for those with IBS. The proposed mental health and sleep benefits may have a flow-on effect in terms of lowering the occurrence of other comorbidities, such as depression and work absenteeism which have economic costs, thereby lowering the burden on the healthcare system and reducing healthcare costs for those with IBS.
Interventions
Fibre-fix (TM) will be provided to participants who have been clinically diagnosed as IBS patients following a low FODMAP diet. Participants will be randomly allocated to intervention or control group, with both researchers and participants blinded to allocation. Participants in either group will take the Fibre-fix or Control supplement (provided in sachets) for 3 weeks. The first four days will be 1 sachet per day, half in the morning and evening, respectively. The remaining 17 days will be 2 s
Fibre-fix (TM) will be provided to participants who have been clinically diagnosed as IBS patients following a low FODMAP diet. Participants will be randomly allocated to intervention or control group, with both researchers and participants blinded to allocation. Participants in either group will take the Fibre-fix or Control supplement (provided in sachets) for 3 weeks. The first four days will be 1 sachet per day, half in the morning and evening, respectively. The remaining 17 days will be 2 sachets per day, one sachet in the morning and evening, respectively. One package of 38 sachets in total will be provided to each participant at Edith Cowan University Joondalup campus by the researcher of the study. Participants will be advised on the best procedure for consuming the supplement, and a booklet of education for consumption and the study journey, which is designed specifically for this study, will be provided along with the package of sachets. Related recipes and instruction of taking the supplement have been outlined in the education booklet. The dietary fibre supplement (Fibre-fix) or control supplement can be consumed by mixing with 250-350ml of water and drinking immediately or sprinkling over regular meals as a part of a daily diet. Sachets were prepared in a food-grade laboratory at Edith Cowan University. For monitoring adherence to the intervention, participants will be received weekly text message reminders and will be required to return the unused sachets which will also allow calculation of the compliance rate. Consumption of greater than 80% of the sachets (30 sachets) over the three-week period will be considered compliant with the study protocols. Additionally, participants will be asked to complete a daily bowel symptoms checklist that has a column for participants to fill out the time and amount of supplement consumed as an additional way of monitoring compliance. Common dietary fibre is low in resistant starch whereas Fibre-fix contains a high content of resistant starch from high amylose maize starch.
Sponsors
Edith Cowan Univeristy
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Participants will be between 18 - 65 years old and have been clinically diagnosed with IBS, meeting the Rome IV edition diagnostic criteria by a gastroenterologist, other medical professional or dietitian. Participants will be on a Low FODMAP Diet for one month prior to the intervention or prepared to restart a Low FODMAP Diet for the duration of the study. Participants will need to be available to attend the local clinic visits and the ECU Joondalup campus, and be willing to consume the intervention starch sachets as per the requirement.
Exclusion criteria
• Smoking, • Pregnancy or planning to become pregnant, • Having a known diagnosis of other gastrointestinal illness (e.g. Inflammatory Bowel Disease, malabsorption of any macronutrients, bowel resection, coeliac disease), • Previous abdominal or gastrointestinal surgeries, severe mental health and sleep-related conditions (e.g. insomnia), renal or hepatic diseases, and major medical illness, • Current use of pharmaceutical agents that could modify or treat IBS (e.g. probiotics, antibiotics, eluxadoline, lubiprostone and linaclotide) or sleep conditions, • Other restrictive dietary patterns or therapies (e.g. gluten-free, low-carbohydrate, or high-protein diets, keto/Paleo-diet), • Take any prebiotics, • Any other disease, condition or habit that may interfere with completion of study.
Outcome results
None listed