Changes in Bile Acid Homeostasis and Stool Habits After Cholecystectomy
BACH
2 other identifiers
interventional
23
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Jun 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 22, 2017
CompletedFirst Posted
Study publicly available on registry
May 30, 2017
CompletedStudy Start
First participant enrolled
June 22, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 15, 2019
CompletedResults Posted
Study results publicly available
May 19, 2022
CompletedMay 19, 2022
July 1, 2021
1.9 years
May 22, 2017
June 8, 2021
March 2, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (10)
Change in Chenodeoxycholic Acid (CDCA) Absorption to Plasma From Baseline Before Versus After Cholecystectomy
baseline and 3 - 5 months after cholecystectomy
Change in Fasting 7-alpha-hydroxy-cholestenone (C4) From Baseline Before Versus After Cholecystectomy
baseline and 3 - 5 months after cholecystectomy
Change in Lipid Status From Baseline Before Versus After Cholecystectomy
baseline and 3 - 5 months after cholecystectomy
Change in Stool Frequency From Baseline Before Versus After Cholecystectomy
baseline and 3 - 5 months after cholecystectomy
Change in Stool Pattern Correlated to FGF19
baseline and 3 - 5 months after cholecystectomy
- +5 more secondary outcomes
Study Arms (1)
Intervention
EXPERIMENTALchenodeoxycholic acid 1250mg po.
Interventions
1250 mg CDCA is given with a study meal
Eligibility Criteria
You may qualify if:
- planned elective cholecystectomy
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Zealand University Hospital
Køge, 4600, Denmark
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Christian Borup, coordinating investigator
- Organization
- Zealand University Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Christian Borup
Zealand University Hosipital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 22, 2017
First Posted
May 30, 2017
Study Start
June 22, 2017
Primary Completion
May 15, 2019
Study Completion
May 15, 2019
Last Updated
May 19, 2022
Results First Posted
May 19, 2022
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will not share