The Role of Faecal Bile Acids in the Management of Bile Acid Diarrhoea (NCT02848040) | Clinical Trial Compass
CompletedNot Applicable
The Role of Faecal Bile Acids in the Management of Bile Acid Diarrhoea
United Kingdom112 participantsStarted 2016-12
Plain-language summary
Bile acid malabsorption (BAM), a common cause of diarrhoea, affects 1 million people in the UK, but is often misdiagnosed as irritable bowel syndrome or goes unrecognised in patients with inflammatory bowel disease.
The SeHCAT (seleno-tauro-homocholic acid) test is currently the only diagnostic test for BAM, but it is not widely available and it is also time consuming, expensive and involves exposure to radioactivity. Some clinicians give a course of blind or empirical treatment instead. The National Institute of Clinical Excellence (NICE) recognised these issues and highlighted the need for cheaper and safer tests to identify BAM.
This study will assess the accuracy of a simple, convenient and inexpensive laboratory test for the rapid diagnosis of BAM which measures bile acids in stool. This test has the potential to have a broad impact on clinical practice and patient care by enabling doctors to identify and treat patients with BAM promptly. Results from the second phase of the study will allow the assessment of the benefits of monitoring the stool test to determine whether the bile acid changes can predict the response to treatment and dosage needed for each patient.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 18 years age and over
* Willing to provide informed consent
* Post-cholecystectomy patients group (n=30; type 3 BAD)
* Post-terminal ileal resection patients with Crohn's disease group (n=30; type 1 BAD)
* D-IBS patients with normal SeHCAT retention group (n=30)
* Idiopathic bile salt diarrhoea with abnormal SeHCAT retention group (type 2 BAD) (n=30)
Exclusion Criteria:
* Pregnancy/ breast feeding
* Patient participating in another trial
* Patients unable to give written consent
* Known established bile salt diarrhoea
* Recipients of antibiotics in under 4 weeks of initial trial participation
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
faecal bile acids retention values.
Timeframe: 12 weeks
2
SeHCAT retention values
Timeframe: 12 weeks
Trial details
NCT IDNCT02848040
SponsorThe Royal Wolverhampton Hospitals NHS Trust