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Expression of BCRP in Icteric Patients

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT00295360
First received: February 17, 2006
Last updated: February 22, 2006
Last verified: March 2005
  Purpose

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 Intervention
Icterus
Behavioral: no intervention, pathophysiological study

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Cross-Sectional
Official Title: Influence of Cholestasis on Intestinal BCRP Expression

Further study details as provided by University Hospital, Basel, Switzerland:

Estimated Enrollment: 40
Study Start Date: June 2003
Estimated Study Completion Date: August 2004
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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:

-

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00295360     History of Changes
Other Study ID Numbers: MDR-108-03
Study First Received: February 17, 2006
Last Updated: February 22, 2006
Health Authority: Switzerland: Ethikkommission

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

ClinicalTrials.gov processed this record on November 20, 2014