None listed
Conditions
Brief summary
Current dietary advice for individuals with an ileoanal pouch is based on general healthy eating guidelines, rather than tailored recommendations. However, people respond to food differently, and it may not be appropriate to recommend the same dietary advice to everyone with a pouch. Our group is conducting a two-phase study to develop more personalised dietary recommendations. Phase 1 (Trial ID: ACTRN12624000912583) involved a lab-based investigation using fresh stool samples to assess how gut microbes break down specific food components. This registration refers to Phase 2, where the same participants will follow two different 7-day diets in a randomised crossover design. Stool samples collected after each diet will be tested using the same in vitro assay developed in Phase 1. The goal is to determine whether the assay can detect meaningful differences in microbial fermentation based on dietary intake. We believe people with an ileoanal pouch respond differently to different diets, and that our lab test can pick up these differences. This could help us move away from one-size-fits-all advice and towards personalised fibre recommendations.
Interventions
Phase 1 (Trial ID: ACTRN12624000912583) involved a laboratory-based study using fresh stool samples to validate an in vitro assay that measures microbial fermentation of different dietary components. This assay uses a gas-sensing system to quantify fermentation but is not a diagnostic tool, nor is it intended to monitor, treat, or prevent disease. All participants in the current study have already taken part in Phase 1.
Phase 2 (this study) is a randomised, crossover dietary intervention design
Phase 1 (Trial ID: ACTRN12624000912583) involved a laboratory-based study using fresh stool samples to validate an in vitro assay that measures microbial fermentation of different dietary components. This assay uses a gas-sensing system to quantify fermentation but is not a diagnostic tool, nor is it intended to monitor, treat, or prevent disease. All participants in the current study have already taken part in Phase 1. Phase 2 (this study) is a randomised, crossover dietary intervention designed to assess whether the in vitro assay can reflect diet-induced changes in fermentation. Participants will complete two 7-day dietary periods that differ in their food composition, separated by a 3-week washout period. Before starting the diets, participants will complete a 3-day habitual diet “run-in” period. They will then be randomised to follow one of the two diets. After the first 7-day diet, a washout period of at least 3 weeks will occur before switching to the second diet for another 7 days. Participants will be provided with food hampers that include both pre-prepared items and ingredients to prepare themselves, covering three meals and snacks per day. The study coordinator (a dietitian) will deliver dietary education via a tailored written handout and a brief verbal session (in person or via phone, depending on participant availability). The education materials have been developed specifically for this study. To support adherence, participants will complete a daily food diary. Participants will provide a total of three stool samples during this study: 1. After the 3-day habitual diet run-in period 2. At the end of the first 7-day diet period 3. At the end of the second 7-day diet period If successful, this work may help support more personalised dietary recommendations for individuals with an ileoanal pouch.
Sponsors
Monash University
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Patients will undergo screening prior to obtaining informed consent for the following criteria: • Aged 18-75 years old • Patients with an ileo-anal pouch • English speaking • Eligible for Medicare
Exclusion criteria
• Patients with antibiotic dependent or antibiotic refractory pouchitis • Use of fibre supplements within 2 weeks • Active pouchitis • History of Crohn’s disease • Inability to provide informed consent • Dietary restrictions, food allergies, intolerances or aversions that will interfere with consuming intervention foods (i.e. veganism, vegetarian, food allergies) • Use of antibiotics, pre or probiotics within the last 4 weeks • History of stricturing ileal or pouch inlet disease • History of recent small bowel obstructions (in the last 2 years)
Outcome results
None listed