Clinical Studies on Bile Acids in Barrett's Esophagus

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Department of Veterans Affairs

ClinicalTrials.gov Identifier:

NCT00858858

First received: March 9, 2009

Last updated: November 17, 2014

Last verified: November 2014

History of Changes

Purpose

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	Intervention
Gastroesophageal Reflux Disease	Drug: Ursodeoxycholic Acid


Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science
Official Title:	Clinical Studies on Bile Acids in Barrett's Esophagus

Resource links provided by NLM:

MedlinePlus related topics: GERD

Drug Information available for: Ursodiol

U.S. FDA Resources

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:

Protection Against DNA Damage by UDCA [ Time Frame: After 8 weeks of UDCA treatment ] [ Designated as safety issue: No ]
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.


Enrollment:	60
Study Start Date:	March 2009
Estimated Study Completion Date:	March 2015
Primary Completion Date:	March 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00858858

Locations


United States, Texas
VA North Texas Health Care System, Dallas
Dallas, Texas, United States, 75216

Sponsors and Collaborators

Department of Veterans Affairs

Investigators


Principal Investigator:	Stuart J Spechler, MD	VA North Texas Health Care System, Dallas

More Information

Publications:

Huo X, Juergens S, Zhang X, Rezaei D, Yu C, Strauch ED, Wang JY, Cheng E, Meyer F, Wang DH, Zhang Q, Spechler SJ, Souza RF. Deoxycholic acid causes DNA damage while inducing apoptotic resistance through NF-κB activation in benign Barrett's epithelial cells. Am J Physiol Gastrointest Liver Physiol. 2011 Aug;301(2):G278-86. doi: 10.1152/ajpgi.00092.2011. Epub 2011 Jun 2.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Peng S, Huo X, Rezaei D, Zhang Q, Zhang X, Yu C, Asanuma K, Cheng E, Pham TH, Wang DH, Chen M, Souza RF, Spechler SJ. In Barrett's esophagus patients and Barrett's cell lines, ursodeoxycholic acid increases antioxidant expression and prevents DNA damage by bile acids. Am J Physiol Gastrointest Liver Physiol. 2014 Jul 15;307(2):G129-39. doi: 10.1152/ajpgi.00085.2014. Epub 2014 May 22.


Responsible Party:	Department of Veterans Affairs
ClinicalTrials.gov Identifier:	NCT00858858 History of Changes
Obsolete Identifiers:	NCT00849420
Other Study ID Numbers:	GAST-002-08F
Study First Received:	March 9, 2009
Results First Received:	November 7, 2014
Last Updated:	November 17, 2014
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:


Barrett Esophagus Gastroesophageal Reflux Deglutition Disorders Digestive System Abnormalities Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders	Gastrointestinal Diseases Ursodeoxycholic Acid Cholagogues and Choleretics Gastrointestinal Agents Pharmacologic Actions Therapeutic Uses

ClinicalTrials.gov processed this record on March 03, 2015

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