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

NCT06259396 | Recruiting DMC

• 1 other identifier: 19094
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Bile Acid Diarrhea

Keywords

diet intervention; nutrition; feasibility; diarrhoea; adults

Outcome Measures

Primary Outcomes (6)

• Consent

  The number (%) of participants who consent to participate in the trial compared to the number (%) that were screened by the research team.

  Recruitment period (50 weeks)

• Recruitment

  The number (%) of participants randomised compared to the number (%) that were eligible (screened by the research team)

  Recruitment period (50 weeks)

• Randomisation

  The number (%) of participants who complete their first appointment compared to the number (%) that were randomised, intervention group only.

  Recruitment period (50 weeks)

• Retention

  Tthe number (%) of participants that completed the study compared to the number (%) randomised to each group.

  Randomisation to trial completion (8 weeks)

• The trial's data collection instruments and procedures: Missing data

  The number and proportion of missing data identified by the research team from questionnaires.

  At baseline and at Week 8

• The trial's data collection instruments and procedures: Participants' views and experiences

  Participants' views and experiences of the instruments (questionnaires and diaries) and procedures (screening, randomisation, baseline period, trial, general)

  Study identification to study completion (Week 8)

Study Arms (2)

The 8x5 Diet

ACTIVE COMPARATOR

The 8x5 Diet is a healthy dietary pattern administered virtually by a specialist dietitian

Behavioral: The 8x5 Diet

Control

NO INTERVENTION

Continuation of habitual diet, no dietary changes.

Interventions

The 8x5 Diet BEHAVIORAL

A virtual, dietitian-counselled, healthy dietary pattern defined by its fat intake, its daily eating pattern, keeping adequately hydrated, having a variety of whole grains, fruit and vegetables, and use of certain plant fibres.

The 8x5 Diet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 months
• Inflammatory bowel disease, previous or current microscopic colitis, or other serious morbidities such as liver disease, pancreatic disease, AIDS/HIV, radiotherapy for cancer, assessed at screening via patient self-report
• Diarrhoea that is inadequately active: \<3 stools per day or \<1 watery stool (Bristol Stool Form types 6-7) per day as the mean of one week
• Currently participating in another research study or has taken part in the previous 3 months
• If taking insulin, metformin (other than slow-release), anti-obesity medication, or using commercially available formulated supplements to replace meals in previous three months
• Use of antibiotics in the previous four weeks
• Food allergies, other than oral allergy syndrome/pollen-food syndrome
• An eating disorder or disordered eating which is active or in the last 12 months
• Alcohol or drug abuse, or self-harm, or depression, or suicide ideation in the last 12 months
• Shift worker
• If unwilling to keep a weighed 7-day food diary

Sponsors & Collaborators

• University of Manchester: lead

Study Sites (1)

Yvonne McKenzie

Manchester, Greater Manchester, M13 9PL, United Kingdom

RECRUITING

Related Publications (1)

• McKenzie YA, Kelman L, O'Connor M, Todd C, Walters JR, Burden S. Diet therapy (The 8x5 Diet) for adults living with bile acid diarrhoea: protocol for a feasibility randomised controlled trial. BMJ Open. 2025 Mar 27;15(3):e097973. doi: 10.1136/bmjopen-2024-097973.

  PMID: 40147991 DERIVED

MeSH Terms

Conditions

Diarrhea

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Christopher Todd, Professor

  The University of Manchester

  STUDY CHAIR

Central Study Contacts

Yvonne McKenzie, MSc

CONTACT

07966878758; yvonne.mckenzie@postgrad.manchester.ac.uk

Sorrel Burden, PhD

CONTACT

0161 306 1508; sorrel.burden@manchester.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Candidate

Model Details: feasibility randomised controlled trial

Study Record Dates

• First Submitted: February 6, 2024
• First Posted: February 14, 2024
• Study Start: April 2, 2024
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: December 16, 2024

Record last verified: 2024-12

Locations

GB (1)