Bile Acid DiarrheaNCT06259396
The 8x5 Diet for Bile Acid Diarrhoea: A Feasibility Randomised Controlled Trial
A study testing The 8x5 Diet in people with Bile Acid Diarrhea, run by University of Manchester at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bile Acid Diarrhea
- What is being tested?
- The 8x5 Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Apr 2024to 31 Mar 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Yvonne McKenzie
Manchester, Greater Manchester, M13 9PL
Yvonne McKenzie, MSc, 07966878758, yvonne.mckenzie@postgrad.manchester.ac.uk
Sorrel Burden, PhD, 0161 306 1508, sorrel.burden@manchester.ac.uk
About this study
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.
Read the 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.
- Conditions
- Bile Acid Diarrhea
- Being tested
- The 8x5 Diet
- Keywords
- diet intervention, nutrition, feasibility, diarrhoea, adults
- Medical subject headings
- Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The 8x5 DietBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| The 8x5 Diet | Active comparator | The 8x5 Diet is a healthy dietary pattern administered virtually by a specialist dietitian Receives: Behavioral: The 8x5 Diet |
| Control | No intervention | Continuation of habitual diet, no dietary changes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Consent
The number (%) of participants who consent to participate in the trial compared to the number (%) that were screened by the research team.
Measured: Recruitment period (50 weeks)
Recruitment
The number (%) of participants randomised compared to the number (%) that were eligible (screened by the research team)
Measured: Recruitment period (50 weeks)
Randomisation
The number (%) of participants who complete their first appointment compared to the number (%) that were randomised, intervention group only.
Measured: Recruitment period (50 weeks)
Retention
Tthe number (%) of participants that completed the study compared to the number (%) randomised to each group.
Measured: Randomisation to trial completion (8 weeks)
The trial's data collection instruments and procedures: Missing data
The number and proportion of missing data identified by the research team from questionnaires.
Measured: At baseline and at Week 8
The trial's data collection instruments and procedures: Participants' views and experiences
Participants' views and experiences of the instruments (questionnaires and diaries) and procedures (screening, randomisation, baseline period, trial, general)
Measured: Study identification to study completion (Week 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start2 Apr 2024
- Primary completion31 Mar 2025 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bile Acid DiarrheaStudies of the same condition, open and under way.
- More trials run by University of ManchesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- feasibility randomised controlled trial
- Masking
- None (open label)
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yvonne McKenzie, University of Manchester
- Investigators
- Christopher Todd, Professor, Study chair, The University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06259396
- Sponsor's protocol ID
- 19094
- Status last verified
- Dec 2024
- First submitted
- 6 Feb 2024
- Last updated
- 16 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
McKenzie YA, Kelman L, O'Connor M, Todd C, Walters JR, Burden S. Diet therapy (The 8x5 Diet) for adults living with bile acid diarrhoea: protocol for a feasibility randomised controlled trial. BMJ Open. 2025 Mar 27;15(3):e097973. doi: 10.1136/bmjopen-2024-097973.
PubMed 40147991
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The 8x5 Diet for Bile Acid Diarrhoea: A Feasibility Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06259396
- Acronym / sponsor ID
- 19094
- Conditions
- Bile Acid Diarrhea
- Keywords
- diet intervention, nutrition, feasibility, diarrhoea, adults
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Study start
- 2 Apr 2024 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 14 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- feasibility randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| The 8x5 Diet | Active comparator | Behavioral: The 8x5 DietThe 8x5 Diet is a healthy dietary pattern administered virtually by a specialist dietitian |
| Control | No intervention | –Continuation of habitual diet, no dietary changes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The 8x5 DietA 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. | Behavioural | The 8x5 Diet |
Primary outcome
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
Time frame: Recruitment period (50 weeks)
The number (%) of participants randomised compared to the number (%) that were eligible (screened by the research team)
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.
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.
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.
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
- Derived from this study: PubMed 40147991McKenzie YA, Kelman L, O'Connor M, Todd C, Walters JR, Burden S. Diet therapy (The 8x5 Diet) for adults living with bile acid diarrhoea: protocol for a feasibility randomised controlled trial. BMJ Open. 2025 Mar 27;15(3):e097973. doi: 10.1136/bmjopen-2024-097973.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christopher Todd, Professor study chair
The University of Manchester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The 8x5 Diet in people with Bile Acid Diarrhea, run by University of Manchester at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yvonne McKenzie, MSc (07966878758, yvonne.mckenzie@postgrad.manchester.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Consent (time frame: Recruitment period (50 weeks)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06259396, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2024.