Validation of Stimulated ∆FGF19 for Diagnosing Bile Acid Diarrhoea
NCT ID: NCT03059537
Last Updated: 2017-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
71 participants
INTERVENTIONAL
2017-03-13
2017-11-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Stimulation Test
Study meal plus chenodeoxycholic acid: 1,250 mg single dose stimulation
Oral chenodeoxycholic acid stimulation
oral intake of chenodeoxycholic acid to stimulate the ileal bile acid transporter and farnesoid X receptor
Interventions
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Oral chenodeoxycholic acid stimulation
oral intake of chenodeoxycholic acid to stimulate the ileal bile acid transporter and farnesoid X receptor
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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).
18 Years
80 Years
ALL
No
Sponsors
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Lars Kristian Munck
OTHER
Responsible Party
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Lars Kristian Munck
DMSci
Principal Investigators
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Christian Borup, MD
Role: PRINCIPAL_INVESTIGATOR
Zealand University Hospital
Locations
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Aalborg University Hospital
Aalborg, , Denmark
Aarhus University Hospital
Aarhus, , Denmark
Zealand University Hopsital
Holbæk, , Denmark
Hvidovre University Hospital
Hvidovre, , Denmark
Zealand University Hospital
Køge, , Denmark
Countries
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References
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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.
Other Identifiers
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SJ-546
Identifier Type: -
Identifier Source: org_study_id