Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT03059537
NCT03059537CompletedPhase 4

Validation of Stimulated ∆FGF19 for Diagnosing Bile Acid Diarrhoea

Lars Kristian Munck5 sites in 1 country71 target enrollmentStarted: March 13, 2017Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Sponsor
Enrollment
71
Locations
5
Primary Endpoint
Negative predictive value of stimulated deltaFGF19
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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).

Arms & Interventions

Stimulation Test

Experimental

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

Intervention: Oral chenodeoxycholic acid stimulation (Drug)

Outcomes

Primary Outcomes

Negative predictive value of stimulated deltaFGF19

Time Frame: 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 Outcomes

  • Other diagnostic and Nosographic propabilities stimulated deltaFGF19, SeHCAT < 10%(Individual data are collected within one week)
  • Diagnostic and Nosographic propabilities of 7alpha-CHO for SeHCAT <5%(Individual data are collected within one week)
  • Correlation of FGF19 to clinical diarrhoea(Individual data are collected within one week)
  • 7alpha-CHO by SeHCAT stratum(Individual data are collected within one week)
  • Other diagnostic and Nosographic propabilities stimulated deltaFGF19, SeHCAT < 5%(Individual data are collected within one week)
  • Diagnostic and Nosographic propabilities of 7alpha-CHO for SeHCAT <10%(Individual data are collected within one week)
  • FGF19 by SeHCAT stratum(Individual data are collected within one week)
  • Correlation of 7alpha-CHO to clinical diarrhoea(Individual data are collected within one week)

Investigators

Sponsor
Lars Kristian Munck
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Lars Kristian Munck

DMSci

Zealand University Hospital

Study Sites (5)

Loading locations...

Similar Trials

Active, not recruiting
Phase 1
Trial to validate a method based on a blood sample to diagnose the disease bile acid diarrhoea
EUCTR2016-002217-22-DKSjællands University Hospital, Køge70
Recruiting
Not Applicable
Preoperative Serum FGF19 in the Prognosis of Biliary AtresiaBiliary AtresiaPrognosis
NCT05848310Children's Hospital of Fudan University200
Completed
Phase 4
Changes in Bile Acid Homeostasis and Stool Habits After CholecystectomyBile Acid MalabsorptionCholelithiasis
NCT03168555Zealand University Hospital23
Completed
Not Applicable
Evaluation of the Gastrointestinal Manifestation of Fabry's DiseaseFabry's Disease
NCT02798458Massachusetts General Hospital48
Withdrawn
Phase 3
Comparison Study for Bile Reflux and Gastric Stasis in Patients After Distal GastrectomyGastrectomyStomach Cancer
NCT00622804The Catholic University of Korea90