N/A
N=60
Clinical Studies on Bile Acids in Barrett's Esophagus
Gastroesophageal Reflux Disease
Bottom Line
View on ClinicalTrials.gov: NCT00858858 ↗Enrolled (actual)
60
Serious AEs
9.5%
Results posted
Nov 2014
Primary outcome: Primary: Protection Against DNA Damage by UDCA — 1.068; .82 Relative Densitometry Units
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Ursodeoxycholic Acid (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- US Department of Veterans Affairs
- Primary completion
- Mar 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Protection Against DNA Damage by UDCA |
1.068; .82 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00858858). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.