search
Back to results

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

Primary Purpose

Bile Acid Malabsorption, Cholelithiasis

Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
chenodeoxycholic acid
Sponsored by
Zealand University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Bile Acid Malabsorption

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Zealand University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

chenodeoxycholic acid 1250mg po.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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.
Change in Fasting 7-alpha-hydroxy-cholestenone (C4) From Baseline Before Versus After Cholecystectomy
Change from baseline to after cholecystectomy in fasting C4
Change in Lipid Status From Baseline Before Versus After Cholecystectomy
Change from baseline to after cholecystectomy in plasma triglycerides
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
Change in Stool Pattern Correlated to FGF19
Spearman correlation between change from baseline to after cholecystectomy in FGF19 and in mean number of stools
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
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
Change in Fasting FGF19 From Baseline Before Versus After Cholecystectomy
change in fasting FGF19 before versus 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
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.

Full Information

First Posted
May 22, 2017
Last Updated
March 2, 2022
Sponsor
Zealand University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT03168555
Brief Title
Changes in Bile Acid Homeostasis and Stool Habits After Cholecystectomy
Acronym
BACH
Official Title
Changes in Bile Acid Homeostasis and Stool Habits After Cholecystectomy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
June 22, 2017 (Actual)
Primary Completion Date
May 15, 2019 (Actual)
Study Completion Date
May 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zealand University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bile Acid Malabsorption, Cholelithiasis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
chenodeoxycholic acid 1250mg po.
Intervention Type
Drug
Intervention Name(s)
chenodeoxycholic acid
Other Intervention Name(s)
CDCA, chenodeoxycholate
Intervention Description
1250 mg CDCA is given with a study meal
Primary Outcome Measure Information:
Title
Change in Stimulated Fibroblast Growth Factor 19 (FGF19) From Baseline Before Versus Post Cholecystectomy
Description
Change from baseline to after cholecystectomy in median chenodeoxycholic acid (CDCA) plus meal stimulated FGF19 (delta 0 min to 150 min after stimulation)
Time Frame
baseline and 3 - 5 months after cholecystectomy
Secondary Outcome Measure Information:
Title
Change in Chenodeoxycholic Acid (CDCA) Absorption to Plasma From Baseline Before Versus After Cholecystectomy
Description
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.
Time Frame
baseline and 3 - 5 months after cholecystectomy
Title
Change in Fasting 7-alpha-hydroxy-cholestenone (C4) From Baseline Before Versus After Cholecystectomy
Description
Change from baseline to after cholecystectomy in fasting C4
Time Frame
baseline and 3 - 5 months after cholecystectomy
Title
Change in Lipid Status From Baseline Before Versus After Cholecystectomy
Description
Change from baseline to after cholecystectomy in plasma triglycerides
Time Frame
baseline and 3 - 5 months after cholecystectomy
Title
Change in Stool Frequency From Baseline Before Versus After Cholecystectomy
Description
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
Time Frame
baseline and 3 - 5 months after cholecystectomy
Title
Change in Stool Pattern Correlated to FGF19
Description
Spearman correlation between change from baseline to after cholecystectomy in FGF19 and in mean number of stools
Time Frame
baseline and 3 - 5 months after cholecystectomy
Title
Change in Patient Reported Diarrhea Symptoms Correlated With Change in C4 From Baseline Before Versus After Cholecystectomy
Description
Correlation between patient reported frequency of diarrhea (gastrointestinal quality of life index item 31) and fasting C4 before versus after cholecystectomy
Time Frame
baseline and 3 - 5 months after cholecystectomy
Title
Change in C4 Total Area Under the Curve From Baseline Before Versus After Cholecystectomy
Description
Change in total AUC for C4 between visit 1 and visit 2
Time Frame
before cholecystectomy and 3-5 months after cholecystectomy
Title
Change in Fasting FGF19 From Baseline Before Versus After Cholecystectomy
Description
change in fasting FGF19 before versus after cholecystectomy
Time Frame
before and 3-5 months after cholecystectomy
Title
Change in Patient Reported Diarrhea Symptoms Correlated With Change in FGF19 From Baseline Before Versus After Cholecystectomy
Description
Correlation between patient reported frequency of diarrhea (gastrointestinal quality of life index item 31) and fasting FGF19 before versus after cholecystectomy
Time Frame
baseline and 3 - 5 months after cholecystectomy
Title
Change in Stool Consistency (Bristol Stool Type) From Baseline Before Versus After Cholecystectomy
Description
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.
Time Frame
baseline and 3 - 5 months after cholecystectomy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Borup
Organizational Affiliation
Zealand University Hosipital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zealand University Hospital
City
Køge
ZIP/Postal Code
4600
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Changes in Bile Acid Homeostasis and Stool Habits After Cholecystectomy

We'll reach out to this number within 24 hrs