Validation of Stimulated ∆FGF19 for Diagnosing Bile Acid Diarrhoea

Phase 4

Completed

• Conditions: Bile Acid Malabsorption
• Interventions: Drug: Oral chenodeoxycholic acid stimulation

• Registration Number: NCT03059537
• Lead Sponsor: Lars Kristian Munck

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-02-02
• Study First Submitted QC: 2017-02-20
• Study First Posted: 2017-02-23
• Study Start: 2017-03-13
• Primary Completion: 2017-11-27
• Study Completion: 2017-11-27
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-11
• Last Update Posted: 2017-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Stimulation Test	Oral chenodeoxycholic acid stimulation	Study meal plus chenodeoxycholic acid: 1,250 mg single dose stimulation

Primary Outcome Measures

Name	Time	Method
Negative predictive value of stimulated deltaFGF19	Individual data are collected within one week	For screening purposes for bile acid diarrhoea. Negative Predictive Value by Receiver Operating Curve analysis for SeHCAT \< 10 %

Secondary Outcome Measures

Name	Time	Method
Correlation of 7alpha-CHO to clinical diarrhoea	Individual data are collected within one week	Correlation of fasting 7alpha-CHO to diarrhoea by stool diary
Other diagnostic and Nosographic propabilities stimulated deltaFGF19, SeHCAT < 10%	Individual data are collected within one week	Positive predictive value, sensitivity and specificity for bile acid diarrhoea judged by FGF19 for SeHCAT \<10%
Diagnostic and Nosographic propabilities of 7alpha-CHO for SeHCAT <5%	Individual data are collected within one week	Positive predictive value, sensitivity and specificity for bile acid diarrhoea judged by 7alpha-CHO for SeHCAT \<5%
Correlation of FGF19 to clinical diarrhoea	Individual data are collected within one week	Correlation of FGF19 (fasting and stimulated deltaFGF19) to diarrhoea by stool diary
7alpha-CHO by SeHCAT stratum	Individual data are collected within one week	Median fasting 7alpha-CHO in SeHCAT stratum: 0-5%, \>5.1-10%, \>10.1-15%, \> 15.1%.
Other diagnostic and Nosographic propabilities stimulated deltaFGF19, SeHCAT < 5%	Individual data are collected within one week	Positive predictive value, sensitivity and specificity for bile acid diarrhoea judged by FGF19 for SeHCAT \<5%
Diagnostic and Nosographic propabilities of 7alpha-CHO for SeHCAT <10%	Individual data are collected within one week	Positive predictive value, sensitivity and specificity for bile acid diarrhoea judged by 7alpha-CHO for SeHCAT \<10%
FGF19 by SeHCAT stratum	Individual data are collected within one week	Median stimulated ∆FGF19 in SeHCAT stratum: 0-5%, \>5.1-10%, \>10.1-15%, \> 15.1%.

Trial Locations

Locations (5)

Aalborg University Hospital; 🇩🇰 Aalborg, Denmark

Hvidovre University Hospital; 🇩🇰 Hvidovre, Denmark

Zealand University Hopsital; 🇩🇰 Holbaek, Denmark

Aarhus University Hospital; 🇩🇰 Aarhus, Denmark

Zealand University Hospital; 🇩🇰 Køge, Denmark