- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03168555
Changes in Bile Acid Homeostasis and Stool Habits After Cholecystectomy (BACH)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Køge, Denmark, 4600
- Zealand University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- planned elective cholecystectomy
Exclusion Criteria:
- small bowel resection
- right sided hemicolectomy
- known chronic diarrheal disease (celiac disease, lactose malabsorption, Inflammatory bowel diseases, incl microscopic colitis)
- pregnancy
- wish for pregnancy within next three months
- allergy to eggs
- allergy to constituents in Xenbilox (capsules with chenodeoxycholic acid)
- acute cholecystitis within two months
- chronic cholecystitis
- cirrhosis of the liver
- suspected obstructive choledocholithiasis
- icterus
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
chenodeoxycholic acid 1250mg po.
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1250 mg CDCA is given with a study meal
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Stimulated Fibroblast Growth Factor 19 (FGF19) From Baseline Before Versus Post Cholecystectomy
Time Frame: baseline and 3 - 5 months after cholecystectomy
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Change from baseline to after cholecystectomy in median chenodeoxycholic acid (CDCA) plus meal stimulated FGF19 (delta 0 min to 150 min after stimulation)
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baseline and 3 - 5 months after cholecystectomy
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Chenodeoxycholic Acid (CDCA) Absorption to Plasma From Baseline Before Versus After Cholecystectomy
Time Frame: baseline and 3 - 5 months after cholecystectomy
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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.
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baseline and 3 - 5 months after cholecystectomy
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Change in Fasting 7-alpha-hydroxy-cholestenone (C4) From Baseline Before Versus After Cholecystectomy
Time Frame: baseline and 3 - 5 months after cholecystectomy
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Change from baseline to after cholecystectomy in fasting C4
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baseline and 3 - 5 months after cholecystectomy
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Change in Lipid Status From Baseline Before Versus After Cholecystectomy
Time Frame: baseline and 3 - 5 months after cholecystectomy
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Change from baseline to after cholecystectomy in plasma triglycerides
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baseline and 3 - 5 months after cholecystectomy
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Change in Stool Frequency From Baseline Before Versus After Cholecystectomy
Time Frame: baseline and 3 - 5 months after cholecystectomy
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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
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baseline and 3 - 5 months after cholecystectomy
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Change in Stool Pattern Correlated to FGF19
Time Frame: baseline and 3 - 5 months after cholecystectomy
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Spearman correlation between change from baseline to after cholecystectomy in FGF19 and in mean number of stools
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baseline and 3 - 5 months after cholecystectomy
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Change in Patient Reported Diarrhea Symptoms Correlated With Change in C4 From Baseline Before Versus After Cholecystectomy
Time Frame: baseline and 3 - 5 months after cholecystectomy
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Correlation between patient reported frequency of diarrhea (gastrointestinal quality of life index item 31) and fasting C4 before versus after cholecystectomy
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baseline and 3 - 5 months after cholecystectomy
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Change in C4 Total Area Under the Curve From Baseline Before Versus After Cholecystectomy
Time Frame: before cholecystectomy and 3-5 months after cholecystectomy
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Change in total AUC for C4 between visit 1 and visit 2
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before cholecystectomy and 3-5 months after cholecystectomy
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Change in Fasting FGF19 From Baseline Before Versus After Cholecystectomy
Time Frame: before and 3-5 months after cholecystectomy
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change in fasting FGF19 before versus after cholecystectomy
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before and 3-5 months after cholecystectomy
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Change in Patient Reported Diarrhea Symptoms Correlated With Change in FGF19 From Baseline Before Versus After Cholecystectomy
Time Frame: baseline and 3 - 5 months after cholecystectomy
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Correlation between patient reported frequency of diarrhea (gastrointestinal quality of life index item 31) and fasting FGF19 before versus after cholecystectomy
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baseline and 3 - 5 months after cholecystectomy
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Change in Stool Consistency (Bristol Stool Type) From Baseline Before Versus After Cholecystectomy
Time Frame: baseline and 3 - 5 months after cholecystectomy
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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.
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baseline and 3 - 5 months after cholecystectomy
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Christian Borup, Zealand University Hosipital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Metabolic Diseases
- Gastrointestinal Diseases
- Intestinal Diseases
- Pathological Conditions, Anatomical
- Gallbladder Diseases
- Biliary Tract Diseases
- Calculi
- Gallstones
- Cholelithiasis
- Cholecystolithiasis
- Malabsorption Syndromes
- Gastrointestinal Agents
- Cathartics
- Chenodeoxycholic Acid
Other Study ID Numbers
- SJ-434
- 2016-004692-53 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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