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Expression of BCRP in Icteric Patients

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ClinicalTrials.gov Identifier: NCT00295360
Recruitment Status : Completed
First Posted : February 23, 2006
Last Update Posted : February 23, 2006
Sponsor:
Information provided by:
University Hospital, Basel, Switzerland

Brief Summary:
The expression of transporters involved in bile acid homeostasis is differentially regulated during obstructive cholestasis. Bile acids are also substrates of the drug efflux transporter breast cancer resistance protein (BCRP) that is highly expressed in the human intestine. Therefore we intend to analyze whether intestinal BCRP expression could be altered during cholestasis.

Condition or disease Intervention/treatment
Icterus Behavioral: no intervention, pathophysiological study

Detailed Description:

BCRP is capable of transport bile acids and may indicate that this transporter is involved in bile acid homeostasis. As an efflux pump, it could protect the enterocytes from potential toxic bile acid concentrations. During cholestasis, where the enterohepatic circulation is disrupted, there occurs an adaptive regulation of transporters for bile acids, bilirubin and cholesterol. These changes take place in liver, kidney, as well as in the intestine.

Using real-time RT-PCR analysis we determine BCRP mRNA expression levels in duodenal tissue of healthy subjects and cholestatic patients. BCRP protein levels will be determined by immunohistochemistry.

Healthy subjects and cholestatic patients are enrolled in the study after giving informed consent. Control subjects with an indication for a gastrointestinal tract endoscopy within a cancer-screening program and patients with obstructive cholestasis with an interventional endoscopic retrograde cholangiopancreatography (ERCP) are included in this study. During endoscopy four biopsy specimens are obtained from the distal part of the duodenum. Biopsies are immediately stored at –70°C until further processing.


Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Cross-Sectional
Time Perspective: Prospective
Official Title: Influence of Cholestasis on Intestinal BCRP Expression
Study Start Date : June 2003
Estimated Study Completion Date : August 2004




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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • clinical diagnosis of obstructive cholestasis (obstructive jaundice was defined on the basis of chemical parameters (bilirubin, g-glutamyltransferase, and alkaline phosphatase) and on imaging procedures (ultrasound and ERCP) demonstrating a dilated bile duct system)
  • control subjects had an indication for a gastrointestinal tract endoscopy within a cancer-screening program

Exclusion Criteria:


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): NCT00295360


Locations
Switzerland
University Basel, Department of Research
Basel, Basel- Stadt, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
Principal Investigator: Jürgen Drewe, MD, MSc Department of Clinical Pharmacology, University Basel

ClinicalTrials.gov Identifier: NCT00295360     History of Changes
Other Study ID Numbers: MDR-108-03
First Posted: February 23, 2006    Key Record Dates
Last Update Posted: February 23, 2006
Last Verified: March 2005

Keywords provided by University Hospital, Basel, Switzerland:
cholestasis
BCRP
multidrug resistance
duodenum
bile acids
ABCG2