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Bile Acid MalabsorptionPhase 4VABADNCT03059537

Validation of Stimulated ∆FGF19 for Diagnosing Bile Acid Diarrhoea

A Phase 4 study testing Oral chenodeoxycholic acid stimulation in people with Bile Acid Malabsorption, run by Lars Kristian Munck at 5 sites in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Bile Acid Malabsorption
What is being tested?
Oral chenodeoxycholic acid stimulation
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
71 participants
Where
5 sitesDenmark
Study dates
13 Mar 2017to 27 Nov 2017
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Consecutive patients referred for SeHCAT

Who cannot join

  • 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.
Show all 13Show fewer
  • 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).

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Denmark5 sites

  • Aalborg University Hospital

    Aalborg, 9000

  • Aarhus University Hospital

    Aarhus, 8000

  • Zealand University Hopsital

    Holbæk, 4300

  • Hvidovre University Hospital

    Hvidovre, 2650

  • Zealand University Hospital

    Køge, 4600

Other trials in Denmark

About this study

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.

Being tested
Oral chenodeoxycholic acid stimulation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Oral chenodeoxycholic acid stimulationDrug

    Also called Chenodeoxycolic acid

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

Study groups in NCT03059537
Study groupRoleWhat they receive
Stimulation TestExperimentalStudy meal plus chenodeoxycholic acid: 1,250 mg single dose stimulation
Receives: Drug: Oral chenodeoxycholic acid stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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 %

    Measured: Individual data are collected within one week

Secondary outcomes (8)

  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%

    Measured: 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%

    Measured: 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%

    Measured: 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%

    Measured: 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

    Measured: 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

    Measured: 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%.

    Measured: 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%.

    Measured: Individual data are collected within one week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Feb 2017
  2. Study start13 Mar 2017
  3. Primary completion27 Nov 2017
  4. Study completion27 Nov 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
71 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03059537
Sponsor's protocol ID
SJ-546
Acronym
VABAD
Status last verified
Dec 2017
First submitted
2 Feb 2017
Last updated
12 Dec 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Oral chenodeoxycholic acid stimulation in people with Bile Acid Malabsorption, run by Lars Kristian Munck at 5 sites in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Negative predictive value of stimulated deltaFGF19 (time frame: Individual data are collected within one week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03059537, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2017.

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