Clinical Studies on Bile Acids in Barrett's Esophagus

Completed · Not applicable

Conditions studied: Gastroesophageal Reflux Disease

In brief

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.

Key facts

Study ID

NCT00858858

Run by

US Department of Veterans Affairs

People needed

60

Starts

2009-03-01

Expected to finish

2015-02-01

Last updated by the study team

2015-04-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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