Changes in Bile Acid Homeostasis and Stool Habits After Cholecystectomy

Cholelithiasis Clinical Trial

— BACH  

Official title:

Changes in Bile Acid Homeostasis and Stool Habits After Cholecystectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03168555
• Other study ID #: SJ-434
• Secondary ID: 2016-004692-53
• Status: Completed
• Phase: Phase 4
• Start date: June 22, 2017
• Est. completion date: May 15, 2019

Study information

• Verified date: July 2021
• Source: Zealand University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: May 15, 2019
• Est. primary completion date: May 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Bile Acid Malabsorption
• Cholecystolithiasis
• Cholelithiasis
• Gallstones
• Malabsorption Syndromes

Intervention

Drug:
• chenodeoxycholic acid
1250 mg CDCA is given with a study meal

Locations

Country	Name	City	State
Denmark	Zealand University Hospital	Køge

Sponsors (1)

Lead Sponsor	Collaborator
Zealand University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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)	baseline and 3 - 5 months after cholecystectomy
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.	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	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	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	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	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	baseline and 3 - 5 months after cholecystectomy
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	before cholecystectomy and 3-5 months after cholecystectomy
Secondary	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
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	baseline and 3 - 5 months after cholecystectomy
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.	baseline and 3 - 5 months after cholecystectomy