NCT00858858

Brief Summary

This study has two major goals:

  1. 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

March 9, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 10, 2009

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

November 24, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

April 30, 2015

Status Verified

April 1, 2015

Enrollment Period

4 years

First QC Date

March 9, 2009

Results QC Date

November 7, 2014

Last Update Submit

April 15, 2015

Conditions

Gastroesophageal Reflux Disease

Outcome Measures

Primary Outcomes (1)

  • Protection Against DNA Damage by UDCA

    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.

    After 8 weeks of UDCA treatment

Study Arms (1)

Arm 1

EXPERIMENTAL

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

Interventions

Ursodeoxycholic AcidDRUG

8 weeks of oral UDCA treatment 10 mg/kg qd

Also known as: UDCA
Arm 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who have been scheduled for elective endoscopic examination at the Dallas VA Medical Center for the evaluation of GERD or Barrett's esophagus

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX

Dallas, Texas, 75216, United States

Location

Related Publications (2)

  • 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-kappaB 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.

    PMID: 21636532BACKGROUND

  • 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.

    PMID: 24852569DERIVED

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Ursodeoxycholic Acid

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Deoxycholic AcidCholic AcidsBile Acids and SaltsSteroidsFused-Ring CompoundsPolycyclic CompoundsCholanes

Results Point of Contact

Title
Stuart Spechler
Organization
VA
Stuart.Spechler@va.gov
214-857-1603

Study Officials

  • Stuart J Spechler, MD

    VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2009

First Posted

March 10, 2009

Study Start

March 1, 2009

Primary Completion

March 1, 2013

Study Completion

February 1, 2015

Last Updated

April 30, 2015

Results First Posted

November 24, 2014

Record last verified: 2015-04

Locations

US(1)