Clinical Studies on Bile Acids in Barrett's Esophagus

This study has been completed.
Information provided by (Responsible Party):
VA Office of Research and Development Identifier:
First received: March 9, 2009
Last updated: April 15, 2015
Last verified: April 2015

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 Intervention
Gastroesophageal Reflux Disease
Drug: Ursodeoxycholic Acid

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Clinical Studies on Bile Acids in Barrett's Esophagus

Resource links provided by NLM:

Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • Protection Against DNA Damage by UDCA [ Time Frame: After 8 weeks of UDCA treatment ] [ Designated as safety issue: No ]
    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.

Enrollment: 60
Study Start Date: March 2009
Study Completion Date: February 2015
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00858858

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
Principal Investigator: Stuart J Spechler, MD VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
  More Information

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: VA Office of Research and Development Identifier: NCT00858858     History of Changes
Obsolete Identifiers: NCT00849420
Other Study ID Numbers: GAST-002-08F
Study First Received: March 9, 2009
Results First Received: November 7, 2014
Last Updated: April 15, 2015
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Barrett Esophagus
Gastroesophageal Reflux
Deglutition Disorders
Digestive System Abnormalities
Digestive System Diseases
Esophageal Diseases
Esophageal Motility Disorders
Gastrointestinal Diseases
Ursodeoxycholic Acid
Cholagogues and Choleretics
Gastrointestinal Agents
Pharmacologic Actions
Therapeutic Uses processed this record on October 09, 2015