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New treatment option for Bile Acid Diarrhea
Official title The 8x5 Diet for Bile Acid Diarrhoea: A Feasibility Randomised Controlled Trial
ClinicalTrials.gov ID: NCT06259396
What this study is testing
- What it's testing
- Bile acid diarrhoea is a common cause of chronic watery diarrhoea. Treatment is life-long medication.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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
You likely can't join 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...
- 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...
See the full eligibility 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.
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Manchester, Greater Manchester, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Manchester, Greater Manchester, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.