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

December 10, 2024 updated by: Yvonne McKenzie, University of Manchester
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Bile acid diarrhoea is a lifelong gastrointestinal disorder that causes non-bloody and often urgent, diarrhoea. It is estimated that 1 in 100 adults in the United Kingdom are affected. To manage the diarrhoeal symptoms, daily oral medication is prescribed. About 50% of people are unable to achieve satisfactory symptom control, therefore other therapeutic options are needed. Recent research found a very high prevalence of perceived food intolerances with many people consequently avoiding foods. Systematic review of diet studies in bile acid diarrhoea showed that fat intake reductions and carbohydrate modification may have a beneficial effect on diarrhoea. However, no studies have been conducted as randomised controlled trials, undertaken outside of a hospital recruitment setting, or have assessed nutritional intakes and diet quality. With this paucity of evidence, The 8x5 Diet has been developed.

This study will be conducted virtually to recruit 76 adults from across the United Kingdom who are living with bile acid diarrhoea, have ongoing diarrhoea, and are without any other serious illnesses. Participants will be randomly allocated for 8 weeks to either their usual diet or to trial The 8x5 Diet with detailed advice from a specialist dietitian. The primary objective is to test the feasibility of the trial relating to consent, recruitment, randomisation, and retention. The results will inform the design of a future, definitive, and larger randomised controlled trial.

Study Type

Interventional

Enrollment (Estimated)

76

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 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

Medically necessary dietary exclusions or issues deemed incompatible with the trial:

  • Food allergies, other than oral allergy syndrome/pollen-food syndrome
  • Exclusion of gluten (i.e. coeliac disease), lactose, biogenic amines, or any other dietary exclusion assessed as unsuitable as screening by the trial team. This includes if the participant knows they would refuse to eat: starchy foods, fruit and vegetables, protein-rich foods, or dairy and alternatives (e.g. following a ketogenic diet)
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: The 8x5 Diet
The 8x5 Diet is a healthy dietary pattern administered virtually by a specialist dietitian
Behavioral: The 8x5 Diet
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.
No Intervention: Control
Continuation of habitual diet, no dietary changes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Retention
Time Frame: Randomisation to trial completion (8 weeks)
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
Time Frame: At baseline and at Week 8
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
Time Frame: Study identification to study completion (Week 8)
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)
Consent
Time Frame: Recruitment period (50 weeks)
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
Time Frame: Recruitment period (50 weeks)
The number (%) of participants randomised compared to the number (%) that were eligible (screened by the research team)
Recruitment period (50 weeks)
Randomisation
Time Frame: Recruitment period (50 weeks)
The number (%) of participants who complete their first appointment compared to the number (%) that were randomised, intervention group only.
Recruitment period (50 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Manchester

Investigators

  • Study Chair: Christopher Todd, Professor, The University of Manchester

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 2, 2024

Primary Completion (Estimated)

March 31, 2025

Study Completion (Estimated)

March 31, 2025

Study Registration Dates

First Submitted

February 6, 2024

First Submitted That Met QC Criteria

February 6, 2024

First Posted (Actual)

February 14, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 10, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19094

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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