Clinical Studies on Bile Acids in Barrett's Esophagus

• Status: Completed
• Trial end date: 2015-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: US Department of Veterans Affairs; VA Office of Research and Development
• Treatments: Bile Acids and Salts; Ursodeoxycholic Acid

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