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Clinical Studies on Bile Acids in Barrett's Esophagus

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ClinicalTrials.gov Identifier: NCT00858858
Recruitment Status : Completed
First Posted : March 10, 2009
Results First Posted : November 24, 2014
Last Update Posted : April 30, 2015
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:

This study has two major goals:

  1. To determine the effects of bile salts on causing DNA injury and activating signaling pathways that promote growth in cells from the esophagus of patients who have gastroesophageal reflux disease (GERD)
  2. To determine whether changes in bile composition induced by treating patients with a bile salt called ursodeoxycholic acid (UDCA) can alter DNA injury, signaling pathway activation and other types of damage in cells from the esophagus of patients who have GERD.

Condition or disease Intervention/treatment Phase
Gastroesophageal Reflux Disease Drug: Ursodeoxycholic Acid Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Clinical Studies on Bile Acids in Barrett's Esophagus
Study Start Date : March 2009
Actual Primary Completion Date : March 2013
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD
Drug Information available for: Ursodiol
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Arm 1
All patients are treated with DCA and UDCA perfusion of the esophagus, one year apart, followed by 8 weeks of treatment with oral ursodeoxycholic acid 10 mg/kg qd. Then a final DCA perfusion of the esophagus.
Drug: Ursodeoxycholic Acid
8 weeks of oral UDCA treatment 10 mg/kg qd
Other Name: UDCA



Primary Outcome Measures :
  1. Protection Against DNA Damage by UDCA [ Time Frame: After 8 weeks of UDCA treatment ]
    p-H2AX levels are a measure of DNA damage. Our major outcome measure is the change in p-H2AX levels, expressed as relative densitometry units, after DCA perfusion in patients treated with oral UDCA. If UDCA protects against bile acid-induced DNA damage, then p-H2AX levels before and after perfusion should not change significantly.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who have been scheduled for elective endoscopic examination at the Dallas VA Medical Center for the evaluation of GERD or Barrett's esophagus

Exclusion Criteria:

  • Patients unwilling or unable to provide informed consent
  • Patients with esophageal carcinomas
  • Patients with esophageal varices
  • Patients taking warfarin or clopidogrel
  • Coagulopathy that precludes safe biopsy of the esophagus
  • Comorbidity that precludes safe participation in the study
  • Allergy to omeprazole or UDCA
  • Pregnancy

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): NCT00858858


Locations
United States, Texas
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
Dallas, Texas, United States, 75216
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Stuart J Spechler, MD VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00858858     History of Changes
Obsolete Identifiers: NCT00849420
Other Study ID Numbers: GAST-002-08F
First Posted: March 10, 2009    Key Record Dates
Results First Posted: November 24, 2014
Last Update Posted: April 30, 2015
Last Verified: April 2015

Additional relevant MeSH terms:
Gastroesophageal Reflux
Barrett Esophagus
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Digestive System Abnormalities
Ursodeoxycholic Acid
Bile Acids and Salts
Cholagogues and Choleretics
Gastrointestinal Agents