Validation of Stimulated ∆FGF19 for Diagnosing Bile Acid Diarrhoea

Bile Acid Malabsorption Clinical Trial

— VABAD  

Official title:

Validation of Stimulated ∆FGF19 for Diagnosing Bile Acid Diarrhoea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03059537
• Other study ID #: SJ-546
• Status: Completed
• Phase: Phase 4
• First received: February 2, 2017
• Last updated: December 11, 2017
• Start date: March 13, 2017
• Est. completion date: November 27, 2017

Study information

• Verified date: December 2017
• Source: Zealand University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: November 27, 2017
• Est. primary completion date: November 27, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Bile Acid Malabsorption
• Diarrhea
• Malabsorption Syndromes

Intervention

Drug:
• Oral chenodeoxycholic acid stimulation
oral intake of chenodeoxycholic acid to stimulate the ileal bile acid transporter and farnesoid X receptor

Locations

Country	Name	City	State
Denmark	Aalborg University Hospital	Aalborg
Denmark	Aarhus University Hospital	Aarhus
Denmark	Zealand University Hopsital	Holbaek
Denmark	Hvidovre University Hospital	Hvidovre
Denmark	Zealand University Hospital	Køge

Sponsors (1)

Lead Sponsor	Collaborator
Lars Kristian Munck

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Negative predictive value of stimulated deltaFGF19	For screening purposes for bile acid diarrhoea. Negative Predictive Value by Receiver Operating Curve analysis for SeHCAT < 10 %	Individual data are collected within one week
Secondary	Other diagnostic and Nosographic propabilities stimulated deltaFGF19, SeHCAT < 10%	Positive predictive value, sensitivity and specificity for bile acid diarrhoea judged by FGF19 for SeHCAT <10%	Individual data are collected within one week
Secondary	Other diagnostic and Nosographic propabilities stimulated deltaFGF19, SeHCAT < 5%	Positive predictive value, sensitivity and specificity for bile acid diarrhoea judged by FGF19 for SeHCAT <5%	Individual data are collected within one week
Secondary	Diagnostic and Nosographic propabilities of 7alpha-CHO for SeHCAT <10%	Positive predictive value, sensitivity and specificity for bile acid diarrhoea judged by 7alpha-CHO for SeHCAT <10%	Individual data are collected within one week
Secondary	Diagnostic and Nosographic propabilities of 7alpha-CHO for SeHCAT <5%	Positive predictive value, sensitivity and specificity for bile acid diarrhoea judged by 7alpha-CHO for SeHCAT <5%	Individual data are collected within one week
Secondary	Correlation of FGF19 to clinical diarrhoea	Correlation of FGF19 (fasting and stimulated deltaFGF19) to diarrhoea by stool diary	Individual data are collected within one week
Secondary	Correlation of 7alpha-CHO to clinical diarrhoea	Correlation of fasting 7alpha-CHO to diarrhoea by stool diary	Individual data are collected within one week
Secondary	FGF19 by SeHCAT stratum	Median stimulated ?FGF19 in SeHCAT stratum: 0-5%, >5.1-10%, >10.1-15%, > 15.1%.	Individual data are collected within one week
Secondary	7alpha-CHO by SeHCAT stratum	Median fasting 7alpha-CHO in SeHCAT stratum: 0-5%, >5.1-10%, >10.1-15%, > 15.1%.	Individual data are collected within one week