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

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.

Study Overview

• Status: Completed
• Conditions: Bile Acid Malabsorption
• Intervention / Treatment: Drug: Oral chenodeoxycholic acid stimulation

• Study Type: Interventional
• Enrollment (Actual): 71
• Phase: Phase 4

Contacts and Locations

Study Locations

• Denmark
  • Aalborg, Denmark, 9000
    • Aalborg University Hospital
  • Aarhus, Denmark, 8000
    • Aarhus University Hospital
  • Holbaek, Denmark, 4300
    • Zealand University Hopsital
  • Hvidovre, Denmark, 2650
    • Hvidovre University Hospital
  • Køge, Denmark, 4600
    • Zealand University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stimulation Test; Study meal plus chenodeoxycholic acid: 1,250 mg single dose stimulation	Drug: Oral chenodeoxycholic acid stimulation; oral intake of chenodeoxycholic acid to stimulate the ileal bile acid transporter and farnesoid X receptor; Other Names: Chenodeoxycolic acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
Correlation of 7alpha-CHO to clinical diarrhoea	Correlation of fasting 7alpha-CHO to diarrhoea by stool diary	Individual data are collected within one week
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
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

Collaborators and Investigators

• Sponsor: Lars Kristian Munck
• Investigators: Principal Investigator: Christian Borup, MD, Zealand University Hospital

Publications and helpful links

General Publications

• Borup C, Wildt S, Rumessen J, Graff J, Bouchelouche PN, Andersen TB, Vinter-Jensen L, Zaremba A, German Jorgensen SP, Gregersen T, Nojgaard C, Timm HB, Rainteau D, Gauliard E, Munck LK. Biochemical Diagnosis of Bile Acid Diarrhea: Prospective Comparison With the 75Seleno-Taurohomocholic Acid Test. Am J Gastroenterol. 2020 Dec;115(12):2086-2094. doi: 10.14309/ajg.0000000000000772. Erratum In: Am J Gastroenterol. 2022 Nov 1;117(11):1885-1886.

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2017
• Primary Completion (Actual): November 27, 2017
• Study Completion (Actual): November 27, 2017

Study Registration Dates

• First Submitted: February 2, 2017
• First Submitted That Met QC Criteria: February 20, 2017
• First Posted (Actual): February 23, 2017

Study Record Updates

• Last Update Posted (Actual): December 12, 2017
• Last Update Submitted That Met QC Criteria: December 11, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Metabolic Diseases; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Intestinal Diseases; Diarrhea; Malabsorption Syndromes; Gastrointestinal Agents; Cathartics; Chenodeoxycholic Acid
• Other Study ID Numbers: SJ-546

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No