None listed
Conditions
Brief summary
Does four weeks of malt extract supplementation in individuals with IBS reduce IBS symptoms, improve gut health and improve quality of life?
Interventions
IBS affects approximately 11.2% population globally and imposes a heavy burden on individual and community. We are investigating whether the consumption of a malt extract will reduce the symptoms of IBS, improve overall health and quality of life.
In a randomised double-blind cross-over design, patients will be consume 15mL of either a malt extract or placebo with meals for a four-week period. Participants will consume the malt extract or placebo twice daily with meals at home and record consu
IBS affects approximately 11.2% population globally and imposes a heavy burden on individual and community. We are investigating whether the consumption of a malt extract will reduce the symptoms of IBS, improve overall health and quality of life. In a randomised double-blind cross-over design, patients will be consume 15mL of either a malt extract or placebo with meals for a four-week period. Participants will consume the malt extract or placebo twice daily with meals at home and record consumption in a daily online survey. A six-week washout period will occur between conditions. Prior to and following the four-week intervention period, anthropometry (height and weight) will be determined. Participants will also complete a 3-day food diary using an online application at the same time points. Prior to, during and following the intervention, participants will be required to complete several questionnaires (illness/adverse events, dietary intake and stool consistency), provide stool (gut microbiome and its metabolites i.e short chain fatty acids) and fasting blood (gut permeability, metabolic profile, immune function markers) samples. Throughout the supplementation period participants will be encouraged to re-introduce foods that have trigged IBS in the past. The diet intervention and re-introduction of these foods will be guided by a trained nutritionist with more than 10 years' of experience and be entirely voluntarily. This reintroduction of foods will assess whether the supplementation has improved gut health to a point of lowering IBS related restrictions on the participants’ diet. The venous blood samples and stool samples will be collected at baseline and post-intervention by a trained phlebotomist. All questionnaires will be collated in the software REDCaps and, where possible, administered online to reduce participant burden and reduce data entry error. The daily questionnaire will also be used to monitor adherence to the intervention. However, if a participant prefers, questionnaires may be completed on hard copies and later transcribed to the online software.
Sponsors
Edith Cowan University
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
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
Male and female participants will be between 18 - 65 years old and have been clinically diagnosed with IBS, meeting the Rome IV edition diagnostic criteria
Exclusion criteria
• Smoking, • Pregnancy or planning to become pregnant, • Breastfeeding, • 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), • Other restrictive dietary patterns or therapies (e.g. gluten-free, low-carbohydrate, or high-protein diets, keto/Paleo-diet), • Taken antibiotics or prebiotics in the past 6 weeks, • Any other known disease, condition or habit that may interfere with completion of study.
Outcome results
None listed