Validation of Stimulated ∆FGF19 for Diagnosing Bile Acid Diarrhoea

• Status: Completed
• Trial end date: 2017-11-27
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lars Kristian Munck
• Treatments: Bile Acids and Salts; Chenodeoxycholic Acid

Criteria

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).