Testing a new diet for managing bile acid diarrhoea

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to assess the feasibility of a dietary intervention called The 8x5 Diet for adults suffering from bile acid diarrhoea, a condition that often leads to chronic watery diarrhoea despite medication. The trial will recruit 76 participants from across the United Kingdom, who will be randomly assigned to either continue their usual diet or follow The 8x5 Diet for 8 weeks, with guidance from a specialist dietitian. The primary goal is to evaluate the practicality of conducting a larger randomized controlled trial by examining aspects such as consent, recruitment, randomization, and retention rates.

Why it matters

Who can join: the full rules

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

Where it's running

• Yvonne McKenzie
  Manchester, Greater Manchester, United Kingdom Recruiting

Study contacts

• Study coordinator: Yvonne McKenzie, MSc
• Email: yvonne.mckenzie@postgrad.manchester.ac.uk
• Phone: 07966878758

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.