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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
United Kingdom
Yvonne McKenzie
RECRUITING
Manchester
Contact Information
Primary
Yvonne McKenzie, MSc
yvonne.mckenzie@postgrad.manchester.ac.uk
07966878758
Backup
Sorrel Burden, PhD
sorrel.burden@manchester.ac.uk
0161 306 1508
Time Frame
Start Date: 2024-04-02
Estimated Completion Date: 2025-03-31
Participants
Target number of participants: 76
Treatments
Active_comparator: The 8x5 Diet
The 8x5 Diet is a healthy dietary pattern administered virtually by a specialist dietitian
No_intervention: Control
Continuation of habitual diet, no dietary changes.
Related Therapeutic Areas
Sponsors
Leads: University of Manchester

This content was sourced from clinicaltrials.gov