Trial Details

Not Recruiting
Basic Information
Clinical ID c2053
Identifier ACTRN12624000912583
Trial Title Microbial fermentative capacity of individuals with ulcerative colitis with an ileoanal pouch compared to a healthy or ulcerative colitis with intact colons: an in vitro study
Trial URL Visit Original Page
Study Information
Study Results

No results available

Conditions Inflammatory bowel disease;Ileoanal pouch;Pouchitis;J pouch;Ulcerative colitis; Inflammatory bowel disease Ileoanal pouch Pouchitis J pouch Ulcerative colitis;Oral and Gastrointestinal - Inflammatory bowel disease;Surgery - Other surgery;Inflammatory and Immune System - Other inflammatory or immune system disorders
Interventions This will be a cross-sectional study involving a single fresh faecal sample collection on one occasion, The in vitro study will consist of a single screening phone call and a single faecal collection that takes place before 12pm on the study day. Pre-study day: Patients will be asked to refrain from eating foods high in oligosaccharides (i.e. garlic/onion), resistant starch (i.e. under-ripe banana, legumes) for 24 h. This is to minimise any residual fibres in the collected stool from impacting on their fermentation profiles. Additionally, participants who are taking loperamide will be asked to cease loperamide for 24 h to aid with the ease of stool collection. They can resume loperamide use following faecal collection. Additionally, subjects will be asked to record their food and fluid intake for a 24-h period prior to collection of a stool sample. A 24hr food diary will be provided to participants to complete, This will provide a snapshot of participants dietary intake and whether this has any influence on the activity of faecal bacteria or gas production. Recording food and fluid intake in the food record may take up to 15 minutes. Study collection day: Participants will be given the option of collecting a freshly passed faecal sample at home or attend a study visit at the Department of Gastroenterology, Alfred Centre to have a fresh faecal sample collected during their visit. This will be communicated to them at the time of the screening phone call. Faecal collection at home: Prior to the collection day, participants will be given instructions on collecting faecal samples and contacting the researcher within 0.5 h of collection. Samples are used within ~1.5 hours of passage to ensure that microbiota are viable. They will be p
Participant Information
Sponsor Monash University
City -
Country/Region Australia
Enrollment Criteria
Sex Requirement ALL
Age Requirement ADULT, OLDER_ADULT
Study Design
Study Type Observational
Phase Not Available
Time Information
Start Date 2025-04-24
Primary Completion Date -
Completion Date -