Changes in Bile Acid Homeostasis and Stool Habits After Cholecystectomy

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-22

Study Completion Date

2019-05-15

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Bile Acid Malabsorption Cholelithiasis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Intervention

chenodeoxycholic acid 1250mg po.

Group Type EXPERIMENTAL

chenodeoxycholic acid

Intervention Type DRUG

1250 mg CDCA is given with a study meal

Interventions

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chenodeoxycholic acid

1250 mg CDCA is given with a study meal

Intervention Type DRUG

Other Intervention Names

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CDCA chenodeoxycholate

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No