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CompletedNCT03059537VABADUpdated Dec 12, 2017

Validation of Stimulated ∆FGF19 for Diagnosing Bile Acid Diarrhoea

A Phase 4 interventional study of Oral chenodeoxycholic acid stimulation in Bile Acid Malabsorption, sponsored by Lars Kristian Munck. Completed at 5 sites in Denmark. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-12-12.

Sponsored by Lars Kristian Munck · Phase 4, Interventional, and Diagnostic

Phase
Phase 4
Study type
Interventional
Enrollment
71
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

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Conditions studied

  • Bile Acid Malabsorption
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In context

Lead sponsor

Lars Kristian Munck is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

- Consecutive patients referred for SeHCAT

Exclusion criteria

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).
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Study design

Phase
Phase 4
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
71 participants (actual)

Study arms

  • Experimental
    Stimulation Test

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

    Drug: Oral chenodeoxycholic acid stimulation

Interventions

  • DrugOral chenodeoxycholic acid stimulation

    oral intake of chenodeoxycholic acid to stimulate the ileal bile acid transporter and farnesoid X receptor

    Also known as: Chenodeoxycolic acid

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What researchers measure

Primary outcomes

  1. Negative predictive value of stimulated deltaFGF19

    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 outcomes

  1. 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%

    Time frame: Individual data are collected within one week

  2. 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%

    Time frame: Individual data are collected within one week

  3. 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%

    Time frame: Individual data are collected within one week

  4. 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%

    Time frame: Individual data are collected within one week

  5. Correlation of FGF19 to clinical diarrhoea

    Correlation of FGF19 (fasting and stimulated deltaFGF19) to diarrhoea by stool diary

    Time frame: Individual data are collected within one week

  6. Correlation of 7alpha-CHO to clinical diarrhoea

    Correlation of fasting 7alpha-CHO to diarrhoea by stool diary

    Time frame: Individual data are collected within one week

  7. FGF19 by SeHCAT stratum

    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

  8. 7alpha-CHO by SeHCAT stratum

    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

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Study locations

5 sites
  • Aalborg University Hospital
    Aalborg, 9000, Denmark
  • Aarhus University Hospital
    Aarhus, 8000, Denmark
  • Zealand University Hopsital
    Holbæk, 4300, Denmark
  • Hvidovre University Hospital
    Hvidovre, 2650, Denmark
  • Zealand University Hospital
    Køge, 4600, Denmark
08

References and documents

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. PubMed 32740083 ↗

Individual participant data

Plan to share: No

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Mar 2017 to primary completion in Nov 2017, 8 months.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 2, 2017
First posted
Feb 23, 2017
StartActual
Mar 13, 2017
Primary completionActual
Nov 27, 2017
CompletionActual
Nov 27, 2017
Last update
Dec 12, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 12, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03059537
Lead sponsor
Lars Kristian Munck
Responsible party
Lars Kristian Munck (DMSci, Zealand University Hospital) — Sponsor-investigator
First posted
Feb 23, 2017
Start date
Mar 13, 2017
Primary completion
Nov 27, 2017
Completion
Nov 27, 2017
Last update
Dec 12, 2017

Study contacts

Christian Borup, MD
principal investigator · Zealand University Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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