Changes in Bile Acid Homeostasis and Stool Habits After Cholecystectomy (BACH)

March 2, 2022 updated by: Zealand University Hospital
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

Study Overview

Status

Completed

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

Interventional

Enrollment (Actual)

23

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Køge, Denmark, 4600
        • Zealand University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
1250 mg CDCA is given with a study meal
Other Names:
  • CDCA
  • chenodeoxycholate

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
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 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
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
Change in Fasting 7-alpha-hydroxy-cholestenone (C4) From Baseline Before Versus After Cholecystectomy
Time Frame: baseline and 3 - 5 months 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
Time Frame: baseline and 3 - 5 months 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
Time Frame: baseline and 3 - 5 months 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
Time Frame: baseline and 3 - 5 months after cholecystectomy
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
Time Frame: baseline and 3 - 5 months 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
Time Frame: before cholecystectomy and 3-5 months 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
Time Frame: before and 3-5 months 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
Time Frame: baseline and 3 - 5 months 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
Time Frame: baseline and 3 - 5 months 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Christian Borup, Zealand University Hosipital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 22, 2017

Primary Completion (Actual)

May 15, 2019

Study Completion (Actual)

May 15, 2019

Study Registration Dates

First Submitted

May 22, 2017

First Submitted That Met QC Criteria

May 24, 2017

First Posted (Actual)

May 30, 2017

Study Record Updates

Last Update Posted (Actual)

May 19, 2022

Last Update Submitted That Met QC Criteria

March 2, 2022

Last Verified

July 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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