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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stimulation Test | Experimental | Study meal plus chenodeoxycholic acid: 1,250 mg single dose stimulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral chenodeoxycholic acid stimulation | Drug | oral intake of chenodeoxycholic acid to stimulate the ileal bile acid transporter and farnesoid X receptor |
|
| Measure | Description | Time Frame |
|---|---|---|
| Negative predictive value of stimulated deltaFGF19 | For screening purposes for bile acid diarrhoea. Negative Predictive Value by Receiver Operating Curve analysis for SeHCAT < 10 % | Individual data are collected within one week |
| Measure | Description | Time Frame |
|---|---|---|
| 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% | Individual data are collected within one week |
| Other diagnostic and Nosographic propabilities stimulated deltaFGF19, SeHCAT < 5% |
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Inclusion Criteria:
- Consecutive patients referred for SeHCAT
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christian Borup, MD | Zealand University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aalborg University Hospital | Aalborg | 9000 | Denmark | |||
| Aarhus University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32740083 | Derived | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 13, 2021 | |
| Reset | Feb 1, 2021 | |
| Release | Aug 11, 2021 | |
| Reset | Sep 9, 2021 | |
| Release | Feb 11, 2022 | |
| Reset | Apr 12, 2022 | |
| Release | Aug 3, 2022 | |
| Reset | May 30, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 13, 2021 | Feb 1, 2021 | |||
| Aug 11, 2021 |
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|
Positive predictive value, sensitivity and specificity for bile acid diarrhoea judged by FGF19 for SeHCAT <5% |
| Individual data are collected within one week |
| 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% | Individual data are collected within one week |
| 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% | Individual data are collected within one week |
| Correlation of FGF19 to clinical diarrhoea | Correlation of FGF19 (fasting and stimulated deltaFGF19) to diarrhoea by stool diary | Individual data are collected within one week |
| Correlation of 7alpha-CHO to clinical diarrhoea | Correlation of fasting 7alpha-CHO to diarrhoea by stool diary | Individual data are collected within one week |
| FGF19 by SeHCAT stratum | Median stimulated ∆FGF19 in SeHCAT stratum: 0-5%, >5.1-10%, >10.1-15%, > 15.1%. | Individual data are collected within one week |
| 7alpha-CHO by SeHCAT stratum | Median fasting 7alpha-CHO in SeHCAT stratum: 0-5%, >5.1-10%, >10.1-15%, > 15.1%. | Individual data are collected within one week |
| Aarhus |
| 8000 |
| Denmark |
| Zealand University Hopsital | Holbæk | 4300 | Denmark |
| Hvidovre University Hospital | Hvidovre | 2650 | Denmark |
| Zealand University Hospital | Køge | 4600 | Denmark |
| Sep 9, 2021 |
| Feb 11, 2022 | Apr 12, 2022 |
| Aug 3, 2022 | May 30, 2023 |