The 8x5 Diet for Bile Acid Diarrhoea: A Feasibility Randomised Controlled Trial
ConditionBile Acid Diarrhea
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Manchester
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
The 8x5 Diet
BehavioralA 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.
Treatment groups
76 Participants
are divided into 2 treatment groupsGroup A: The 8x5 DietActive comparator 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Consent
The number (%) of participants who consent to participate in the trial compared to the number (%) that were screened by the research team.
Time frame
Recruitment period (50 weeks)2
Recruitment
The number (%) of participants randomised compared to the number (%) that were eligible (screened by the research team)
Time frame
Recruitment period (50 weeks)3
Randomisation
The number (%) of participants who complete their first appointment compared to the number (%) that were randomised, intervention group only.
Time frame
Recruitment period (50 weeks)4
Retention
Tthe number (%) of participants that completed the study compared to the number (%) randomised to each group.
Time frame
Randomisation to trial completion (8 weeks)Sponsors and contacts
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Source ClinicalTrials.gov