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Trial record 9 of 92 for:    Recruiting, Not yet recruiting, Available Studies | "Malabsorption Syndromes"

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

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ClinicalTrials.gov Identifier: NCT03168555
Recruitment Status : Recruiting
First Posted : May 30, 2017
Last Update Posted : May 15, 2018
Sponsor:
Information provided by (Responsible Party):
Zealand University Hospital

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

Condition or disease Intervention/treatment Phase
Bile Acid Malabsorption Cholelithiasis Drug: chenodeoxycholic acid Phase 4

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  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Changes in Bile Acid Homeostasis and Stool Habits After Cholecystectomy
Actual Study Start Date : June 22, 2017
Estimated Primary Completion Date : September 30, 2018
Estimated Study Completion Date : September 30, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Chenodiol

Arm Intervention/treatment
Experimental: Intervention
chenodeoxycholic acid 1250mg po.
Drug: chenodeoxycholic acid
1250 mg CDCA is given with a study meal
Other Names:
  • CDCA
  • chenodeoxycholate




Primary Outcome Measures :
  1. Change in FGF19 [ Time Frame: baseline and 3 - 5 months after cholecystectomy ]
    Change from baseline to after cholecystectomy in median CDCA plus meal stimulated FGF19 (delta 0 min to 150 min after stimulation)


Secondary Outcome Measures :
  1. Change in CDCA absorption [ Time Frame: baseline and 3 - 5 months after cholecystectomy ]
    Change from baseline to after cholecystectomy in median CDCA plus meal stimulated absorption of CDCA to measured in plasma (total area under the CDCA curve)

  2. Change in CDCA absorption [ Time Frame: baseline and 3 - 5 months after cholecystectomy ]
    Change from baseline to after cholecystectomy in median CDCA plus meal stimulated absorption of CDCA to measured in plasma (repeated measures ANOVA)

  3. Change in C4 [ Time Frame: baseline and 3 - 5 months after cholecystectomy ]
    Change from baseline to after cholecystectomy in median C4

  4. Change in lipid status [ Time Frame: baseline and 3 - 5 months after cholecystectomy ]
    Change from baseline to after cholecystectomy in plasma lipid profile (triglycerides, cholesterols - total, HDL, and LDL)

  5. Change in stool pattern [ Time Frame: baseline and 3 - 5 months after cholecystectomy ]
    Change from baseline to after cholecystectomy in number of stools and Bristol stool form by means of a seven-day diary kept at baseline and after cholecystectomy

  6. Change in stool pattern correlated to FGF19 [ Time Frame: baseline and 3 - 5 months after cholecystectomy ]
    Change from baseline to after cholecystectomy in number of stools and Bristol stool form correlated to FGF19

  7. Change in abdominal symptoms [ Time Frame: baseline and 3 - 5 months after cholecystectomy ]
    Disregarding bile colics abdominal symptoms before and after cholecystectomy are compared when correlated to change in FGF19 and C4



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03168555


Contacts
Contact: Christian Borup, MD 004523328035 chrbo@regionsjaelland.dk
Contact: Lars K Munck, DMSci lkmu@regionsjaelland.dk

Locations
Denmark
Zealand University Hospital Recruiting
Køge, Denmark, 4600
Contact: Christian Borup, MD         
Principal Investigator: Christian Borup, MD         
Sponsors and Collaborators
Zealand University Hospital
Investigators
Principal Investigator: Christian Borup Zealand University Hosipital

Responsible Party: Zealand University Hospital
ClinicalTrials.gov Identifier: NCT03168555     History of Changes
Other Study ID Numbers: SJ-434
2016-004692-53 ( EudraCT Number )
First Posted: May 30, 2017    Key Record Dates
Last Update Posted: May 15, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Malabsorption Syndromes
Cholelithiasis
Cholecystolithiasis
Gallstones
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases
Biliary Tract Diseases
Gallbladder Diseases
Calculi
Pathological Conditions, Anatomical
Bile Acids and Salts
Chenodeoxycholic Acid
Gastrointestinal Agents
Cathartics