Ursodiol in Treating Patients With Barrett Esophagus and Low-Grade Dysplasia
|ClinicalTrials.gov Identifier: NCT01097304|
Recruitment Status : Completed
First Posted : April 1, 2010
Results First Posted : May 15, 2015
Last Update Posted : December 19, 2017
|Condition or disease||Intervention/treatment||Phase|
|Barrett Esophagus Esophageal Carcinoma||Drug: Ursodiol Other: Laboratory Biomarker Analysis||Phase 2|
I. To evaluate the ability of UDCA (ursodiol) treatment to reverse oxidative deoxyribonucleic acid (DNA) damage in the esophageal epithelium of subjects with Barrett's esophagus.
I. To determine the effects of UDCA treatment on gastric bile acid composition and on cell proliferation in Barrett's epithelium.
Patients receive ursodiol orally (PO) twice daily (BID) for 6 months in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed up for 2 weeks.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Study of Ursodeoxycholic Acid in Barrett's Patients|
|Study Start Date :||April 2010|
|Actual Primary Completion Date :||April 2014|
|Actual Study Completion Date :||July 2014|
Experimental: Treatment (ursodiol)
Patients receive ursodiol PO BID for 6 months in the absence of disease progression or unacceptable toxicity.
Other: Laboratory Biomarker Analysis
- Reversal of Oxidative DNA Damage as Assessed by Changes in 8-hydroxy-2' -Deoxyguanosine (8OHdG) Immunostaining [ Time Frame: Baseline to 6 months ]8OHdG will be assessed by percentage of positively stained nuclear area. A paired t-test at a one-sided 0.05 significance level will be used to assess change during intervention. The observed results will be reported along with the corresponding confidence intervals.
- Changes in Gastric Bile Acid Composition (Change in Percent of Total Bile Acid Present as Ursodeoxycholic Acid and Its Glycine/Taurine Conjugates) Measured by Liquid Chromatography-tandem Mass Spectrometry, From Baseline to Post-intervention [ Time Frame: Baseline and 6 months ]
- Changes in Gastric Bile Acid Composition (Change in Percent of Total Bile Acid Present as Deoxycholic Acid and Its Glycine/Taurine Conjugates) Measured by Liquid Chromatography-tandem Mass Spectrometry, From Baseline to Post-intervention [ Time Frame: Baseline and 6 months ]
- Changes in Cell Proliferation in BE Epithelium From Baseline to Post-intervention as Assessed by Proliferation-related Ki-67 Antigen (Ki67) Immunostaining, Percentage of Positively Stained Nuclei, in BE Tissue Sections [ Time Frame: Baseline and 6 months ]Results will be analyzed using paired t-tests. Results (mean values and changes during intervention) will be reported along with the corresponding confidence intervals.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01097304
|United States, Arizona|
|Southern Arizona Veterans Affairs Health Center|
|Tucson, Arizona, United States, 85723|
|Arizona Cancer Center-North Campus|
|Tucson, Arizona, United States, 85724-5024|
|University of Arizona Health Sciences Center|
|Tucson, Arizona, United States, 85724|
|United States, North Carolina|
|University of North Carolina|
|Chapel Hill, North Carolina, United States, 27599|
|Principal Investigator:||Bhaskar Banerjee||University of Arizona Health Sciences Center|