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

Primary Purpose

Bile Acid Malabsorption

Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Oral chenodeoxycholic acid stimulation
Sponsored by
Lars Kristian Munck
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Bile Acid Malabsorption

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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).

Sites / Locations

  • Aalborg University Hospital
  • Aarhus University Hospital
  • Zealand University Hopsital
  • Hvidovre University Hospital
  • Zealand University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Stimulation Test

Arm Description

Study meal plus chenodeoxycholic acid: 1,250 mg single dose stimulation

Outcomes

Primary Outcome Measures

Negative predictive value of stimulated deltaFGF19
For screening purposes for bile acid diarrhoea. Negative Predictive Value by Receiver Operating Curve analysis for SeHCAT < 10 %

Secondary Outcome Measures

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%
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%
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%
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%
Correlation of FGF19 to clinical diarrhoea
Correlation of FGF19 (fasting and stimulated deltaFGF19) to diarrhoea by stool diary
Correlation of 7alpha-CHO to clinical diarrhoea
Correlation of fasting 7alpha-CHO to diarrhoea by stool diary
FGF19 by SeHCAT stratum
Median stimulated ∆FGF19 in SeHCAT stratum: 0-5%, >5.1-10%, >10.1-15%, > 15.1%.
7alpha-CHO by SeHCAT stratum
Median fasting 7alpha-CHO in SeHCAT stratum: 0-5%, >5.1-10%, >10.1-15%, > 15.1%.

Full Information

First Posted
February 2, 2017
Last Updated
December 11, 2017
Sponsor
Lars Kristian Munck
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1. Study Identification

Unique Protocol Identification Number
NCT03059537
Brief Title
Validation of Stimulated ∆FGF19 for Diagnosing Bile Acid Diarrhoea
Acronym
VABAD
Official Title
Validation of Stimulated ∆FGF19 for Diagnosing Bile Acid Diarrhoea
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
March 13, 2017 (Actual)
Primary Completion Date
November 27, 2017 (Actual)
Study Completion Date
November 27, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Lars Kristian Munck

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bile Acid Malabsorption

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
71 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stimulation Test
Arm Type
Experimental
Arm Description
Study meal plus chenodeoxycholic acid: 1,250 mg single dose stimulation
Intervention Type
Drug
Intervention Name(s)
Oral chenodeoxycholic acid stimulation
Other Intervention Name(s)
Chenodeoxycolic acid
Intervention Description
oral intake of chenodeoxycholic acid to stimulate the ileal bile acid transporter and farnesoid X receptor
Primary Outcome Measure Information:
Title
Negative predictive value of stimulated deltaFGF19
Description
For screening purposes for bile acid diarrhoea. Negative Predictive Value by Receiver Operating Curve analysis for SeHCAT < 10 %
Time Frame
Individual data are collected within one week
Secondary Outcome Measure Information:
Title
Other diagnostic and Nosographic propabilities stimulated deltaFGF19, SeHCAT < 10%
Description
Positive predictive value, sensitivity and specificity for bile acid diarrhoea judged by FGF19 for SeHCAT <10%
Time Frame
Individual data are collected within one week
Title
Other diagnostic and Nosographic propabilities stimulated deltaFGF19, SeHCAT < 5%
Description
Positive predictive value, sensitivity and specificity for bile acid diarrhoea judged by FGF19 for SeHCAT <5%
Time Frame
Individual data are collected within one week
Title
Diagnostic and Nosographic propabilities of 7alpha-CHO for SeHCAT <10%
Description
Positive predictive value, sensitivity and specificity for bile acid diarrhoea judged by 7alpha-CHO for SeHCAT <10%
Time Frame
Individual data are collected within one week
Title
Diagnostic and Nosographic propabilities of 7alpha-CHO for SeHCAT <5%
Description
Positive predictive value, sensitivity and specificity for bile acid diarrhoea judged by 7alpha-CHO for SeHCAT <5%
Time Frame
Individual data are collected within one week
Title
Correlation of FGF19 to clinical diarrhoea
Description
Correlation of FGF19 (fasting and stimulated deltaFGF19) to diarrhoea by stool diary
Time Frame
Individual data are collected within one week
Title
Correlation of 7alpha-CHO to clinical diarrhoea
Description
Correlation of fasting 7alpha-CHO to diarrhoea by stool diary
Time Frame
Individual data are collected within one week
Title
FGF19 by SeHCAT stratum
Description
Median stimulated ∆FGF19 in SeHCAT stratum: 0-5%, >5.1-10%, >10.1-15%, > 15.1%.
Time Frame
Individual data are collected within one week
Title
7alpha-CHO by SeHCAT stratum
Description
Median fasting 7alpha-CHO in SeHCAT stratum: 0-5%, >5.1-10%, >10.1-15%, > 15.1%.
Time Frame
Individual data are collected within one week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Borup, MD
Organizational Affiliation
Zealand University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aalborg University Hospital
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
Facility Name
Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark
Facility Name
Zealand University Hopsital
City
Holbaek
ZIP/Postal Code
4300
Country
Denmark
Facility Name
Hvidovre University Hospital
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
Facility Name
Zealand University Hospital
City
Køge
ZIP/Postal Code
4600
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32740083
Citation
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.
Results Reference
derived

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Validation of Stimulated ∆FGF19 for Diagnosing Bile Acid Diarrhoea

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