Diet therapy (The 8×5 Diet) for adults living with bile acid diarrhoea: protocol for a feasibility randomised controlled trial.

Abstract

A national research priority for people living with bile acid diarrhoea (BAD) is effective treatment options to improve their quality of life. This study aims to evaluate the feasibility of conducting a randomised controlled trial (RCT) of a novel healthy dietary pattern (The 8×5 Diet) to inform a future, larger trial. We plan to enrol 76 UK adults living with BAD and ongoing diarrhoea using self-selection sampling and digital technologies. Eligible participants will be assigned to groups using permuted block randomisation using 1:1 allocation to receive either 8 weeks of usual care or The 8×5 Diet using one-to-one, dietitian counselling via a video-conferencing platform and developed digital resources. Randomisation, consent, recruitment, retention and acceptability will be evaluated using data from the RCT and post-trial interviews conducted with those in the intervention group. Secondary outcome exploratory assessment will include health-related quality of life, symptom relief, diarrhoea, diet quality, nutrient intakes and diet satisfaction. Ethical approval was granted by the University of Manchester Research Ethics Committee (2024-19094-33261; V1.7, last updated: 24/02/2025).Findings will be disseminated through peer-reviewed publication, conference presentation and social media. NCT06259396.