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

Recruiting now · Not applicable

Conditions studied: Bile Acid Diarrhea

In brief

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.

Key facts

Study ID: NCT06259396
Run by: University of Manchester
People needed: 76
Starts: 2024-04-02
Expected to finish: 2025-03-31
Last updated by the study team: 2024-12-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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: \&lt;3 stools per day or \&lt;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 is running

Yvonne McKenzie — Manchester, Greater Manchester, United Kingdom (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.