Clinical Studies on Bile Acids in Barrett's Esophagus
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00858858 |
Recruitment Status :
Completed
First Posted : March 10, 2009
Results First Posted : November 24, 2014
Last Update Posted : April 30, 2015
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This study has two major goals:
- 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)
- 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 or disease | Intervention/treatment | Phase |
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Gastroesophageal Reflux Disease | Drug: Ursodeoxycholic Acid | Not Applicable |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 60 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Basic Science |
Official Title: | Clinical Studies on Bile Acids in Barrett's Esophagus |
Study Start Date : | March 2009 |
Actual Primary Completion Date : | March 2013 |
Actual Study Completion Date : | February 2015 |

Arm | Intervention/treatment |
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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.
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Drug: Ursodeoxycholic Acid
8 weeks of oral UDCA treatment 10 mg/kg qd
Other Name: UDCA |
- Protection Against DNA Damage by UDCA [ Time Frame: After 8 weeks of UDCA treatment ]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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00858858
United States, Texas | |
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX | |
Dallas, Texas, United States, 75216 |
Principal Investigator: | Stuart J Spechler, MD | VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | US Department of Veterans Affairs |
ClinicalTrials.gov Identifier: | NCT00858858 |
Obsolete Identifiers: | NCT00849420 |
Other Study ID Numbers: |
GAST-002-08F |
First Posted: | March 10, 2009 Key Record Dates |
Results First Posted: | November 24, 2014 |
Last Update Posted: | April 30, 2015 |
Last Verified: | April 2015 |
Barrett Esophagus Gastroesophageal Reflux Esophageal Motility Disorders Deglutition Disorders Esophageal Diseases Gastrointestinal Diseases |
Digestive System Diseases Precancerous Conditions Neoplasms Ursodeoxycholic Acid Cholagogues and Choleretics Gastrointestinal Agents |