Clinical Studies on Bile Acids in Barrett's Esophagus
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|ClinicalTrials.gov Identifier: NCT00858858|
Recruitment Status : Completed
First Posted : March 10, 2009
Results First Posted : November 24, 2014
Last Update Posted : April 30, 2015
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|
|Gastroesophageal Reflux Disease||Drug: Ursodeoxycholic Acid||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|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|
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.
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.
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|