Validation of Stimulated ∆FGF19 for Diagnosing Bile Acid Diarrhoea (VABAD)

Lars Kristian Munck

Status and phase

Completed

Phase 4

Conditions

Bile Acid Malabsorption

Treatments

Drug: Oral chenodeoxycholic acid stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT03059537

SJ-546

Details and patient eligibility

About

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.

Enrollment

71 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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).