Validation of Stimulated ∆FGF19 for Diagnosing Bile Acid Diarrhoea (NCT03059537) | Clinical Trial Compass
CompletedPhase 4
Validation of Stimulated ∆FGF19 for Diagnosing Bile Acid Diarrhoea
Denmark71 participantsStarted 2017-03-13
Plain-language summary
This study aims to validate a possible diagnostic test for bile acid diarrhoea prospectively compared to the SeHCAT scintigraphy. Fasting participants are given a standard meal and 1,250 mg chenodeoxycholic acid. The investigators measure fasting FGF19, bile acids species including 7-alpha-CHO and serial blood samples after the stimulation.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
\- Consecutive patients referred for SeHCAT
Exclusion Criteria:
* Treatment with sequestrants within one week before the SeHCAT.
* Treatment with any constipants/laxatives one day before the SeHCAT, with the exception of opioids, if the dosis has been stable in the prior 2 weeks.
* Pregnancy, screening by pregnancy test before inclusion.
* Breastfeeding women.
* Small bowel resection, including right sided hemicolectomy.
* Any ongoing treatment for inflammatory bowel disease with systemic steroids (i.e. budesonide or prednisone) or treatment in the prior 4 weeks.
* Allergies to constituents of Xenbilox: (chenodeoxycholic acid, cornflour, magnesium stearate, highly dispersed silica, gelatine, sodium dodecylsulphate, titanium dioxide (E171), quinolone yellow (E104), erythrosine (E127)
* Chronic or acute cholecystitis.
* Liver cirrhosis,
* Obstructed bile flow causing jaundice or elevated p-bilirubin (\> 1,5 UNL).
* Known disability in gall bladder contractility.
* Bile duct atresia.
* Frequent gallstone attacks (\>2/month).
What they're measuring
1
Negative predictive value of stimulated deltaFGF19
Timeframe: Individual data are collected within one week