Clinical trial NCT03059537: Validation of Stimulated ∆FGF19 for Diagnosing Bile Acid Diarrhoea
Official title: Validation of Stimulated ∆FGF19 for Diagnosing Bile Acid Diarrhoea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bile Acid Malabsorption
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
First posted: 2017-02-23
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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).

Primary outcomes:
measure: Negative predictive value of stimulated deltaFGF19
timeFrame: Individual data are collected within one week
Secondary outcomes:
measure: Other diagnostic and Nosographic propabilities stimulated deltaFGF19, SeHCAT < 10%
timeFrame: Individual data are collected within one week
measure: Other diagnostic and Nosographic propabilities stimulated deltaFGF19, SeHCAT < 5%
timeFrame: Individual data are collected within one week
measure: Diagnostic and Nosographic propabilities of 7alpha-CHO for SeHCAT <10%
timeFrame: Individual data are collected within one week
measure: Diagnostic and Nosographic propabilities of 7alpha-CHO for SeHCAT <5%
timeFrame: Individual data are collected within one week
measure: Correlation of FGF19 to clinical diarrhoea
timeFrame: Individual data are collected within one week
measure: Correlation of 7alpha-CHO to clinical diarrhoea
timeFrame: Individual data are collected within one week
measure: FGF19 by SeHCAT stratum
timeFrame: Individual data are collected within one week
measure: 7alpha-CHO by SeHCAT stratum
timeFrame: Individual data are collected within one week
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Holbaek
country: Denmark
facility: Zealand University Hopsital
city: Hvidovre
country: Denmark
facility: Hvidovre University Hospital
city: Køge
country: Denmark
facility: Zealand University Hospital
Study officials:
affiliation: Zealand University Hospital
name: Christian Borup, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.