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Recruiting NCT06259396

The 8x5 Diet for Bile Acid Diarrhoea: A Feasibility Randomised Controlled Trial

Trial Parameters

Condition Bile Acid Diarrhea
Sponsor University of Manchester
Study Type INTERVENTIONAL
Phase N/A
Enrollment 76
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-04-02
Completion 2025-03-31
Interventions
The 8x5 Diet

Brief Summary

Bile acid diarrhoea is a common cause of chronic watery diarrhoea. Treatment is life-long medication. However, about 50% of people have ongoing, bothersome diarrhoea. Findings from recent research on diet therapies and food intolerances have been used to develop a healthy dietary pattern called The 8x5 Diet. We will test the practicalities of conducting a randomised controlled trial of this dietary intervention.

Eligibility Criteria

Inclusion Criteria: * Age ≥ 18 years, of any ethnic group, living in the United Kingdom and not planning to move home for the next three months * Self-reported diagnosis of bile acid diarrhoea that was confirmed by 7-day SeHCAT testing * Self-reported ongoing chronic diarrhoea despite use of appropriate medication * Able to participate in either diet group with the intention to remain in the group to which they were assigned for the 8 week study period * Body mass index ≥20 kg m-2 * Able to converse in English (or via their carer, without assistance from an interpreter) using a computer/laptop, smart phone, or tablet * Able to provide informed written consent * Able to provide the address of their general practioner so that the research team can inform them of their participation. Exclusion Criteria: * Unable to provide self-reported written confirmation that their diagnosis of bile acid diarrhoea was by SeHCAT testing * Pregnant/breastfeeding/planning a pregnancy in the next six month

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