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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-004692-53 | EudraCT Number |
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Investigate serial plasma samples of fibroblast growth factor 19 (FGF19) after oral stimulation with chenodeoxycholic acid in the same subjects before and after elective cholecystectomy
Lack of FGF19 and elevated 7-alpha-hydroxy-colestenone (C4) is associated with the bile acid diarrhoea (BAD), a disease with increasing estimated of prevalence.
BAD is occasionally triggered by cholecystectomy and FGF19 and C4 is known to be affected by cholecystectomy. The investigators are exploring if FGF19 after oral stimulation can be developed to a universal test for BAD, and need to know how the proposed test is affected by cholecystectomy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | chenodeoxycholic acid 1250mg po. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| chenodeoxycholic acid | Drug | 1250 mg CDCA is given with a study meal |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Stimulated Fibroblast Growth Factor 19 (FGF19) From Baseline Before Versus Post Cholecystectomy | Change from baseline to after cholecystectomy in median chenodeoxycholic acid (CDCA) plus meal stimulated FGF19 (delta 0 min to 150 min after stimulation) | baseline and 3 - 5 months after cholecystectomy |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Chenodeoxycholic Acid (CDCA) Absorption to Plasma From Baseline Before Versus After Cholecystectomy | Change from baseline to after cholecystectomy in median unconjugated CDCA plus meal stimulated absorption of unconjugated CDCA to measured in plasma (total area under the CDCA curve with measurement at fasting ie. t=0 minutes and subsequently at 60, 90, 120, and finally at 150minutes. | baseline and 3 - 5 months after cholecystectomy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christian Borup | Zealand University Hosipital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zealand University Hospital | Køge | 4600 | Denmark |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | chenodeoxycholic acid 1250mg po. chenodeoxycholic acid: 1250 mg CDCA is given with a study meal |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Visit 1 (Pro-operative) |
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| ||||||||||||||||||
| Visit 2 (Post-operative) |
|
23 patients enrolled but one dropped out before visit 1. Baseline characteristics therefore only are available for 22
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | chenodeoxycholic acid 1250mg po. chenodeoxycholic acid: 1250 mg CDCA is given with a study meal |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Stimulated Fibroblast Growth Factor 19 (FGF19) From Baseline Before Versus Post Cholecystectomy | Change from baseline to after cholecystectomy in median chenodeoxycholic acid (CDCA) plus meal stimulated FGF19 (delta 0 min to 150 min after stimulation) | Posted | Median | Inter-Quartile Range | pg per mL | baseline and 3 - 5 months after cholecystectomy |
|
Adverse events were registered in relation to administration of chenodeoxycholic acid both at visit 1 and visit 2 (separated by 3-5 months). Registration started at time of administration of chenodeoxycholic acid (one dose) and the registration lasted four days after this. At day three after the administration standard liver biochemistry was measured (ALT, Alk. phospatase, INR, bilirubin).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Visit 1 | chenodeoxycholic acid 1250mg po. chenodeoxycholic acid: 1250 mg CDCA is given with a study meal |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | SNOMED CT | Systematic Assessment | SNOMED CT: 25064002 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Christian Borup, coordinating investigator | Zealand University Hospital | +4523328035 | chrbo@regionsjaelland.dk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 18, 2017 | Feb 28, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002769 | Cholelithiasis |
| ID | Term |
|---|---|
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D002635 | Chenodeoxycholic Acid |
| ID | Term |
|---|---|
| D003840 | Deoxycholic Acid |
| D002793 | Cholic Acids |
| D001647 | Bile Acids and Salts |
| D013256 | Steroids |
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| Change in Fasting 7-alpha-hydroxy-cholestenone (C4) From Baseline Before Versus After Cholecystectomy | Change from baseline to after cholecystectomy in fasting C4 | baseline and 3 - 5 months after cholecystectomy |
| Change in Lipid Status From Baseline Before Versus After Cholecystectomy | Change from baseline to after cholecystectomy in plasma triglycerides | baseline and 3 - 5 months after cholecystectomy |
| Change in Stool Frequency From Baseline Before Versus After Cholecystectomy | Change from baseline to after cholecystectomy in number of stools as a mean of a seven-day diary baseline versus after cholecystectomy. That is the diary results for each study participant is tallied using mean values. The tallying of these diary results is done using medians. Therefore the unit used is 'mean stools per day' and this is reported with medians | baseline and 3 - 5 months after cholecystectomy |
| Change in Stool Pattern Correlated to FGF19 | Spearman correlation between change from baseline to after cholecystectomy in FGF19 and in mean number of stools | baseline and 3 - 5 months after cholecystectomy |
| Change in Patient Reported Diarrhea Symptoms Correlated With Change in C4 From Baseline Before Versus After Cholecystectomy | Correlation between patient reported frequency of diarrhea (gastrointestinal quality of life index item 31) and fasting C4 before versus after cholecystectomy | baseline and 3 - 5 months after cholecystectomy |
| Change in C4 Total Area Under the Curve From Baseline Before Versus After Cholecystectomy | Change in total AUC for C4 between visit 1 and visit 2 | before cholecystectomy and 3-5 months after cholecystectomy |
| Change in Fasting FGF19 From Baseline Before Versus After Cholecystectomy | change in fasting FGF19 before versus after cholecystectomy | before and 3-5 months after cholecystectomy |
| Change in Patient Reported Diarrhea Symptoms Correlated With Change in FGF19 From Baseline Before Versus After Cholecystectomy | Correlation between patient reported frequency of diarrhea (gastrointestinal quality of life index item 31) and fasting FGF19 before versus after cholecystectomy | baseline and 3 - 5 months after cholecystectomy |
| Change in Stool Consistency (Bristol Stool Type) From Baseline Before Versus After Cholecystectomy | Change from baseline to after cholecystectomy in mean Bristol type per stool as of a seven-day diary baseline versus after cholecystectomy. The Bristol scale divides stool into seven categories from 1 (hard lumps) to 7 (completely watery stool). The diary shows pictograms with short text descriptions. | baseline and 3 - 5 months after cholecystectomy |
|
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
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| Secondary | Change in Chenodeoxycholic Acid (CDCA) Absorption to Plasma From Baseline Before Versus After Cholecystectomy | Change from baseline to after cholecystectomy in median unconjugated CDCA plus meal stimulated absorption of unconjugated CDCA to measured in plasma (total area under the CDCA curve with measurement at fasting ie. t=0 minutes and subsequently at 60, 90, 120, and finally at 150minutes. | compares visit 1 with visit 2 | Posted | Median | Inter-Quartile Range | µM * minutes | baseline and 3 - 5 months after cholecystectomy |
|
|
|
| Secondary | Change in Fasting 7-alpha-hydroxy-cholestenone (C4) From Baseline Before Versus After Cholecystectomy | Change from baseline to after cholecystectomy in fasting C4 | paired t-test of lognormalized values | Posted | Mean | 95% Confidence Interval | ng/mL | baseline and 3 - 5 months after cholecystectomy |
|
|
|
|
| Secondary | Change in Lipid Status From Baseline Before Versus After Cholecystectomy | Change from baseline to after cholecystectomy in plasma triglycerides | visit 1 compared with visit 2 | Posted | Median | Inter-Quartile Range | mmol/L | baseline and 3 - 5 months after cholecystectomy |
|
|
|
|
| Secondary | Change in Stool Frequency From Baseline Before Versus After Cholecystectomy | Change from baseline to after cholecystectomy in number of stools as a mean of a seven-day diary baseline versus after cholecystectomy. That is the diary results for each study participant is tallied using mean values. The tallying of these diary results is done using medians. Therefore the unit used is 'mean stools per day' and this is reported with medians | Posted | Median | Inter-Quartile Range | mean stools per day | baseline and 3 - 5 months after cholecystectomy |
|
|
|
|
| Secondary | Change in Stool Pattern Correlated to FGF19 | Spearman correlation between change from baseline to after cholecystectomy in FGF19 and in mean number of stools | Posted | Number | Spearman correlation coefficient | baseline and 3 - 5 months after cholecystectomy |
|
|
|
|
| Secondary | Change in Patient Reported Diarrhea Symptoms Correlated With Change in C4 From Baseline Before Versus After Cholecystectomy | Correlation between patient reported frequency of diarrhea (gastrointestinal quality of life index item 31) and fasting C4 before versus after cholecystectomy | Posted | Number | Spearman correlation coefficient | baseline and 3 - 5 months after cholecystectomy |
|
|
|
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| Secondary | Change in C4 Total Area Under the Curve From Baseline Before Versus After Cholecystectomy | Change in total AUC for C4 between visit 1 and visit 2 | Posted | Mean | 95% Confidence Interval | ng/mL x minutes | before cholecystectomy and 3-5 months after cholecystectomy |
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|
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| Secondary | Change in Fasting FGF19 From Baseline Before Versus After Cholecystectomy | change in fasting FGF19 before versus after cholecystectomy | Posted | Mean | 95% Confidence Interval | pg per mL | before and 3-5 months after cholecystectomy |
|
|
|
|
| Secondary | Change in Patient Reported Diarrhea Symptoms Correlated With Change in FGF19 From Baseline Before Versus After Cholecystectomy | Correlation between patient reported frequency of diarrhea (gastrointestinal quality of life index item 31) and fasting FGF19 before versus after cholecystectomy | Posted | Number | Spearman correlation coefficient | baseline and 3 - 5 months after cholecystectomy |
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|
|
|
| Secondary | Change in Stool Consistency (Bristol Stool Type) From Baseline Before Versus After Cholecystectomy | Change from baseline to after cholecystectomy in mean Bristol type per stool as of a seven-day diary baseline versus after cholecystectomy. The Bristol scale divides stool into seven categories from 1 (hard lumps) to 7 (completely watery stool). The diary shows pictograms with short text descriptions. | Posted | Median | Inter-Quartile Range | Bristol stool type | baseline and 3 - 5 months after cholecystectomy |
|
|
|
|
| 0 |
| 22 |
| 0 |
| 22 |
| 22 |
| 22 |
| EG001 | Visit 2 | chenodeoxycholic acid 1250mg po. chenodeoxycholic acid: 1250 mg CDCA is given with a study meal | 0 | 18 | 0 | 18 | 15 | 18 |
| Migraine | Nervous system disorders | SNOMED CT | Systematic Assessment | SNOMED CT: 37796009 |
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| Dizzyness | Nervous system disorders | SNOMED CT | Systematic Assessment | SNOMED CT: 404640003 |
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| Fatigue | General disorders | SNOMED CT | Systematic Assessment | SNOMED CT:224960004 |
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| Abdominal bloating | Gastrointestinal disorders | SNOMED CT | Systematic Assessment | SNOMED CT: 116289008 |
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| Nausea | Gastrointestinal disorders | SNOMED CT | Systematic Assessment | SNOMED CT: 422587007 |
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| Diarrhea | Gastrointestinal disorders | SNOMED CT | Systematic Assessment | SNOMED CT:62315008 |
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| Burping | Gastrointestinal disorders | SNOMED CT | Systematic Assessment | SNOMED CT: 271834000 |
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| Abdominal pain | Gastrointestinal disorders | SNOMED CT | Systematic Assessment | SNOMED CT: 21522001 |
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| Heartburn | Gastrointestinal disorders | SNOMED CT | Systematic Assessment | SNOMED CT:16331000 |
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| Malaise | General disorders | SNOMED CT | Systematic Assessment | SNOMED CT:367391008 |
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| Abdominal sounds/growling | Gastrointestinal disorders | SNOMED CT | Systematic Assessment | SNOMED CT: 249503000 |
|
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| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D002757 | Cholanes |
| Other |
| Other |