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Validation of Stimulated ∆FGF19 for Diagnosing Bile Acid Diarrhoea (VABAD)

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ClinicalTrials.gov Identifier: NCT03059537
Recruitment Status : Completed
First Posted : February 23, 2017
Last Update Posted : December 12, 2017
Sponsor:
Information provided by (Responsible Party):
Lars Kristian Munck, Zealand University Hospital

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.

Condition or disease Intervention/treatment Phase
Bile Acid Malabsorption Drug: Oral chenodeoxycholic acid stimulation Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Validation of Stimulated ∆FGF19 for Diagnosing Bile Acid Diarrhoea
Actual Study Start Date : March 13, 2017
Actual Primary Completion Date : November 27, 2017
Actual Study Completion Date : November 27, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea
Drug Information available for: Chenodiol

Arm Intervention/treatment
Experimental: Stimulation Test
Study meal plus chenodeoxycholic acid: 1,250 mg single dose stimulation
Drug: Oral chenodeoxycholic acid stimulation
oral intake of chenodeoxycholic acid to stimulate the ileal bile acid transporter and farnesoid X receptor
Other Name: Chenodeoxycolic acid




Primary Outcome Measures :
  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 Outcome Measures :
  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%.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03059537


Locations
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Denmark
Aalborg University Hospital
Aalborg, Denmark, 9000
Aarhus University Hospital
Aarhus, Denmark, 8000
Zealand University Hopsital
Holbaek, Denmark, 4300
Hvidovre University Hospital
Hvidovre, Denmark, 2650
Zealand University Hospital
Køge, Denmark, 4600
Sponsors and Collaborators
Lars Kristian Munck
Investigators
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Principal Investigator: Christian Borup, MD Zealand University Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Lars Kristian Munck, DMSci, Zealand University Hospital
ClinicalTrials.gov Identifier: NCT03059537    
Other Study ID Numbers: SJ-546
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: December 12, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Malabsorption Syndromes
Diarrhea
Signs and Symptoms, Digestive
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases
Chenodeoxycholic Acid
Cathartics
Gastrointestinal Agents