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 range18 Years

SexALL

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

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