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Gastroenterology and hepatology
Protocol
Diet therapy (The 8×5 Diet) for adults living with bile acid diarrhoea: protocol for a feasibility randomised controlled trial
  1. Yvonne A McKenzie1,2,
  2. Lawrence Kelman3,
  3. Michelle O’Connor3,
  4. Chris Todd1,
  5. Julian RF Walters4,
  6. Sorrel Burden1,5
  1. 1Faculty of Biology, Medicine and Health, The University of Manchester, Manchester, UK
  2. 2Nuffield Health The Manor Hospital, Oxford, UK
  3. 3BAD UK, Manchester, UK
  4. 4Faculty of Medicine, Department of Metabolism, Digestion and Reproduction, Imperial College London, London, UK
  5. 5Salford Royal Hospital, Northern Care, Alliance Foundation Trust, Salford, UK
  1. Correspondence to Yvonne A McKenzie; yvonne.mckenzie{at}postgrad.manchester.ac.uk

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.

  • Clinical Protocols
  • Adult gastroenterology
  • NUTRITION & DIETETICS
http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/bmjopen-2024-097973

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    Footnotes

    • X @digestnutrition, @Prof_Chris_Todd

    • Contributors All authors contributed to the design of the study. The manuscript was drafted by YM.All authors read and approved the final manuscript. SB is the guarantor.

    • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

    • Competing interests None declared.

    • Patient and public involvement Patients and/or the public were involved in the design, conduct, reporting or dissemination plans of this research. Refer to the Methods section for further details.

    • Provenance and peer review Not commissioned; externally peer-reviewed.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.