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Clinical Studies on Bile Acids in Barrett's Esophagus

NCT00858858 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2015-04-30

Study results available
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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.

Conditions

  • Gastroesophageal Reflux Disease

Interventions

DRUG

Ursodeoxycholic Acid

8 weeks of oral UDCA treatment 10 mg/kg qd

Sponsors & Collaborators

Principal Investigators

  • Stuart J Spechler, MD · VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2013-03-31
Completion
2015-02-28

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00858858 on ClinicalTrials.gov