RecruitingACTRN12624000912583

Fermentation characteristics of individuals with patients with an ileoanal pouch compared to ulcerative colitis and a healthy colon

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


Sponsor

Monash University

Enrollment

50 participants

Start Date

Jan 20, 2025

Study Type

Observational

Conditions

Summary

Our study investigates how fibre is broken down by the microbiota of patients who have undergone ileoanal pouch surgery, a procedure where the colon is removed and the small intestine is reshaped to act as a new storage area for waste. We aim to understand how fibre fermentation varies among these patients and compare it to individuals with a healthy colon. This research is crucial because dietary fibre, known for its beneficial effects on gut function, may behave differently in the altered digestive anatomy of pouch patients, potentially influencing inflammation and symptom management. By clarifying these relationships, we hope to provide tailored dietary recommendations that can optimise the well-being and quality of life for patients with an ileoanal pouch.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 75 Yearss

Plain Language Summary

Simplified for easier understanding

This study is exploring how dietary fibre is processed in people who have had a specific bowel surgery called an ileoanal pouch procedure — an operation that removes the colon and reshapes the small intestine to create a new storage area for waste. For these patients, the usual relationship between dietary fibre and gut health may work differently, and understanding this could lead to much better dietary advice for this group. Researchers will recruit three groups: people with an ileoanal pouch with active inflammation (pouchitis), people with an ileoanal pouch without inflammation, people with ulcerative colitis, and healthy controls. Participants will provide stool and other samples so researchers can study how their gut bacteria ferment different fibres. The goal is to give people with pouches more personalised dietary guidance that could reduce inflammation and improve their quality of life. You may be eligible if you are aged 18 to 75, live in metropolitan Melbourne, can read and speak English, and are eligible for Medicare. The study needs people with UC-pouches (with or without pouchitis), people with ulcerative colitis (with or without active disease), and healthy controls. People with Crohn's disease, coeliac disease, or who have taken prebiotics or antibiotics recently are not eligible. The study is run by Monash University at The Alfred.

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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 collect

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 participant's 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 posted a faecal collection kit containing toilet liners, instructions, gloves, a biohazard safety bag and a container with an anaerobic strip for collection in the mail. They will also be provided with a padded envelope and box to place the biohazard bag into for transport. As soon as a faecal sample has been passed, participants will contact the researcher immediately who will then organise for the faecal sample to be collected via courier and transported to Monash Clayton for processing. Faecal collection at the Alfred Centre or at Monash University: Patients will have the option to attend for a study visit at either School of Translational Medicine, Monash University located at The Alfred Centre or Biomedicine Discovery Institute (ground floor) Monash University, Clayton for sample collection. Patients will be met by the study coordinator at The Alfred Centre (ground floor) or Monash Biomedicine Discovery Institute (ground floor) and be provided with the faecal collection kit and a $ 10 food and drink voucher so they can purchase food and drink whilst waiting for the faecal collection. Once the patient feels the urge to use their bowels or empty their pouch, they will be asked to use the available toilets for sample collection. Patients at will be shown by a member of the research team appropriate toilets to use. Those at Monash Clayton at will be shown to the toilets at ground floor of the Monash Biomedicine Discovery Research Institute and those at the School of Translational Medicine will be shown to level 6 toilets. Once safely collected, these will be provided back to the study coordinator for immediate sample processing. Protocol: During the visit, a single freshly passed faecal sample will be collected into a sealed plastic takeaway container containing an anaerobic strip. Gloves and instructions will be provided to participants either on the day of stool collection if they attend a visit, or it will be posted to them if they collect the sample at home. It is expected that the actual sample collection will take no longer than 15 minutes, however, the amount of time spent at The Alfred will depend on the frequency of bowel motions experienced by patients. Patients will be asked to ideally attend for a study visit at the usual bowel/pouch emptying times, to avoid unnecessary waiting.


Locations(1)

The Alfred - Melbourne

VIC, Australia

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ACTRN12624000912583


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