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Completed

NCT Number: NCT03168555

Changes in Bile Acid Homeostasis and Stool Habits After Cholecystectomy

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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Key information

Conditions

Bile Acid Malabsorption Biliary Tract Diseases Cholelithiasis Digestive System Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Zealand University Hospital

Køge, 4600, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chenodeoxycholic Acid

Drug

1250 mg CDCA is given with a study meal

Other names: CDCA, chenodeoxycholate

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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.

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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.

Sponsors and collaborators

Lead sponsor

Zealand University Hospital

Other

Registry information

Acronym: BACH

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
May 30, 2017
Registry last updated
May 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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