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Completed

NCT Number: NCT03059537

Validation of Stimulated ∆FGF19 for Diagnosing Bile Acid Diarrhoea

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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Key information

Conditions

Bile Acid Malabsorption

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Aalborg University Hospital, Aalborg, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Oral chenodeoxycholic acid stimulation

Drug

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

Other names: Chenodeoxycolic acid

Primary outcomes

  1. 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

  1. Other diagnostic and Nosographic propabilities stimulated deltaFGF19, SeHCAT < 10%

    Time frame: Individual data are collected within one week

    Positive predictive value, sensitivity and specificity for bile acid diarrhoea judged by FGF19 for SeHCAT <10%

  2. Other diagnostic and Nosographic propabilities stimulated deltaFGF19, SeHCAT < 5%

    Time frame: Individual data are collected within one week

    Positive predictive value, sensitivity and specificity for bile acid diarrhoea judged by FGF19 for SeHCAT <5%

  3. Diagnostic and Nosographic propabilities of 7alpha-CHO for SeHCAT <10%

    Time frame: Individual data are collected within one week

    Positive predictive value, sensitivity and specificity for bile acid diarrhoea judged by 7alpha-CHO for SeHCAT <10%

  4. Diagnostic and Nosographic propabilities of 7alpha-CHO for SeHCAT <5%

    Time frame: Individual data are collected within one week

    Positive predictive value, sensitivity and specificity for bile acid diarrhoea judged by 7alpha-CHO for SeHCAT <5%

  5. Correlation of FGF19 to clinical diarrhoea

    Time frame: Individual data are collected within one week

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

  6. Correlation of 7alpha-CHO to clinical diarrhoea

    Time frame: Individual data are collected within one week

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

  7. FGF19 by SeHCAT stratum

    Time frame: Individual data are collected within one week

    Median stimulated ∆FGF19 in SeHCAT stratum: 0-5%, >5.1-10%, >10.1-15%, > 15.1%.

  8. 7alpha-CHO by SeHCAT stratum

    Time frame: Individual data are collected within one week

    Median fasting 7alpha-CHO in SeHCAT stratum: 0-5%, >5.1-10%, >10.1-15%, > 15.1%.

Sponsors and collaborators

Lead sponsor

Lars Kristian Munck

Other

Registry information

Acronym: VABAD

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Feb 23, 2017
Registry last updated
Dec 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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