Diet therapy (The 8×5 Diet) for adults living with bile acid diarrhoea: protocol for a feasibility randomised controlled trial
File(s)
Published version
Author(s)
Type
Journal Article
Abstract
Introduction 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.
Methods and analysis 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.
Ethics and dissemination 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.
Trial registration number NCT06259396.
Methods and analysis 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.
Ethics and dissemination 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.
Trial registration number NCT06259396.
Date Issued
2025-03-01
Date Acceptance
2025-03-07
Citation
BMJ Open, 2025, 15 (3)
ISSN
2044-6055
Publisher
BMJ Publishing Group
Journal / Book Title
BMJ Open
Volume
15
Issue
3
Copyright Statement
© Author(s) (or their employer(s)) 2025. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ Group.
License URL
Identifier
https://www.ncbi.nlm.nih.gov/pubmed/40147991
PII: bmjopen-2024-097973
Subjects
Adult gastroenterology
Clinical Protocols
NUTRITION & DIETETICS
Humans
Diarrhea
Bile Acids and Salts
Feasibility Studies
Quality of Life
Adult
Randomized Controlled Trials as Topic
United Kingdom
Diet Therapy
Male
Female
Publication Status
Published
Coverage Spatial
England
Article Number
e097973
Date Publish Online
2025-03-27