CompletedNot Applicable

Serum Metabolics-based Method for Diagnosing Bile Acid Diarrhoea

Denmark150 participantsStarted 2024-05-31

Plain-language summary

Bile acid diarrhoea (BAD) is a common yet under-diagnosed and under-recognised disease. The primary symptoms are watery diarrhoea with high frequency of unpredictable bowel movements,urgency and faecal incontinence making BAD a debilitating condition. One of the challenges of BAD is the lack of a readily available and accurate diagnostic test. The aim of this study is to validate a BAD diagnostic score (BDS) based on metabolomics.

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: * SeHCAT referral for suspected bile acid diarrhoea * Age ≥18 years Exclusion Criteria: * Diabetes, except type 2 diabetes * Nephropathy with estimated glomerular filtration rate \<30 min/1.73 m2 * Treatment with medicine that cannot be paused for 12 hours * Hypothyroidism or hyperthyroidism, if not well regulated * Active or recent (\<6 months since last treatment) malignant disease * Any treatment or condition requiring acute or subacute medical or surgical intervention * Any condition considered incompatible with trial participation by the investigators

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

AUROC curve of the BDS in the validation cohort

Timeframe: 1 year from now

Trial details

NCT IDNCT06548009

SponsorUniversity Hospital, Gentofte, Copenhagen

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-04-15

View on ClinicalTrials.gov More Bile Acid Malabsorption trials