RecruitingACTRN12624000016538

Dietary and lifestyle predictors of pouchitis

Longitudinal study of diet, lifestyle and biomarker predictors of pouchitis


Sponsor

Monash University

Enrollment

82 participants

Start Date

Jan 11, 2024

Study Type

Observational

Conditions

Summary

Pouchitis is the most common inflammatory condition for those living with an ileoanal pouch (whereby the large bowel is removed due to medically unresponsive ulcerative colitis (UC) or familial adenomatous polyposis (FAP) and its cause is largely unknown. We aim to assess whether specific diet components and psychological factors such as stress can predict pouchitis. We also aim to assess whether faecal calprotectin (a marker of inflammation found in faeces) can be used as a test to predict worsening in pouch function or pouchitis. This study will follow patients with an ileoanal pouch prospectively for 18 months to evaluate if diet, stress and faecal calprotectin play a role in predicting pouchitis or worsening of pouchitis. This is important because there are currently no dietary guidelines to help ileoanal pouch patients.


Eligibility

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

Plain Language Summary

Simplified for easier understanding

Pouchitis is a painful inflammatory condition that affects people who have had surgery to remove their large bowel, usually because of severe ulcerative colitis or a hereditary bowel condition called familial adenomatous polyposis. After this surgery, a small internal pouch is constructed from the small bowel, and pouchitis — inflammation of this pouch — is the most common complication. Despite how common it is, very little is known about what triggers flare-ups, and there are no dietary guidelines to help patients manage it. This study will follow people with an ileoanal pouch for 18 months, asking them to regularly report what they eat and how they are feeling emotionally. Participants will also collect small stool samples at home to measure a protein called faecal calprotectin, which indicates inflammation. Researchers hope to identify specific foods or stress patterns that predict when pouchitis worsens, which could lead to the first evidence-based dietary guidelines for pouch patients. You may be eligible if you are aged 18 to 75, live in Australia with an ileoanal pouch, have access to the internet, and are eligible for Medicare. You are not eligible if you have chronic antibiotic-refractory pouchitis — meaning pouchitis that has not responded to at least four weeks of combination antibiotics.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

We will be following individuals with an ileoanal pouch over 18 months to identify if dietary factors or psychological stress are environmental factors that can predict the onset or worsening of pouch

We will be following individuals with an ileoanal pouch over 18 months to identify if dietary factors or psychological stress are environmental factors that can predict the onset or worsening of pouchitis. Participants will complete 3-day food diaries, complete a series of online questionnaires related to their pouch function and stress as well as collecting biological samples. Data will be collected online every 6 months, and biological samples will be collected at home and posted back to researchers. Secondly, from the data we collected, we will be assessing how useful faecal calprotectin can be used as a prognostic marker for the development or worsening of pouchitis. In order to achieve this, we will be collecting information about what participants eat, how their pouch functions, their stress levels and psychological wellbeing. Faecal calprotectin in their stools will be collected and hair samples as a retrospective way of looking at the stress hormone, cortisol to identify chronic stress. Dietary intake will be assessed on its overall ‘healthfulness’ and used to find underlying relationships with pouchitis.


Locations(1)

The Alfred - Melbourne

VIC, Australia

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ACTRN12624000016538


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