The Role of HIF-2a in the Pathogenesis of Reflux Esophagitis

This study is currently recruiting participants.
Verified February 2013 by Dallas VA Medical Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Stuart Spechler, Dallas VA Medical Center
ClinicalTrials.gov Identifier:
NCT01733810
First received: November 16, 2012
Last updated: February 27, 2013
Last verified: February 2013
  Purpose

The purpose of this study is to determine the role of hypoxia inducible factor (HIF)-2a on the production of inflammatory cytokines that lead to reflux esophagitis.


Condition Intervention
Esophagitis
Reflux Esophagitis
Gastroesophageal Reflux Disease
Other: Cessation of Acid Suppressing Medications

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: The Role of HIF-2a in the Pathogenesis of Reflux Esophagitis

Resource links provided by NLM:


Further study details as provided by Dallas VA Medical Center:

Primary Outcome Measures:
  • change in esophageal inflammation from baseline to 14 days [ Time Frame: day 0 and day 14 ] [ Designated as safety issue: No ]
    inflammation of the squamous esophageal mucosa will be measured at baseline and at 14 days


Secondary Outcome Measures:
  • change in HIF-2a levels from baseline to 14 days [ Time Frame: day 0 and day 14 ] [ Designated as safety issue: No ]
    Amount of HIF-2a present will be measured at baseline and at 14 days


Estimated Enrollment: 15
Study Start Date: February 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Reflux Patients
Patients with reflux and a prior history of reflux esophagitis are being enrolled. The intervention is cessation of acid-suppressing medications.
Other: Cessation of Acid Suppressing Medications
Acid-suppressing medications are stopped for all participants the day after baseline assessment. Subsequent evaluations performed while participant is not on acid-suppressing medications.

Detailed Description:

Reflux esophagitis is thought to be caused by gastric acid that refluxes into the esophagus, causing injury. Newer data suggest that reflux of gastric juice into the esophagus stimulates HIF-2a, which increases production of inflammatory cytokines. These cytokines are thought to lead to reflux esophagitis. The investigators plan to study the relationship of HIF-2a to inflammatory cytokines in patients with known gastroesophageal reflux disease and reflux esophagitis.

  Eligibility

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

Inclusion Criteria:

  • U.S Veteran
  • History of Los Angeles Grade C erosive esophagitis

Exclusion Criteria:

  • Inability to provide informed consent
  • Esophageal varices
  • Warfarin use
  • Coagulopathy that precludes safe biopsy of the esophagus
  • Comorbidity that precludes safe participation in the study
  • Allergy to fluorescein sodium
  • Pregnancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01733810

Contacts
Contact: Kerry B. Dunbar, MD, PhD 214-857-1603 Kerry.Dunbar@va.gov
Contact: Stuart J. Spechler, MD 214-857-1603 Stuart.Spechler@va.gov

Locations
United States, Texas
Dallas VA Medical Center Recruiting
Dallas, Texas, United States, 75216
Principal Investigator: Stuart J. Spechler, MD         
Sub-Investigator: Kerry B. Dunbar, MD, PhD         
Sub-Investigator: Rhonda Souza, MD         
Dallas VA Medical Center Recruiting
Dallas, Texas, United States, 75216
Contact: Kerry B. Dunbar, MD, MPH    214-857-1603    Kerry.Dunbar@va.gov   
Contact: Stuart J Spechler, MD    214-857-1603    Stuart.Spechler@va.gov   
Sub-Investigator: Ronda Souza, MD         
Sub-Investigator: Kerry B. Dunbar, MD, PhD         
Sponsors and Collaborators
Dallas VA Medical Center
Investigators
Principal Investigator: Stuart J Spechler, MD Dallas VA Medical Center
  More Information

No publications provided

Responsible Party: Stuart Spechler, Professor of Medicine, Dallas VA Medical Center
ClinicalTrials.gov Identifier: NCT01733810     History of Changes
Other Study ID Numbers: 2R01DK063621-11, R01DK063621
Study First Received: November 16, 2012
Last Updated: February 27, 2013
Health Authority: United States: Federal Government

Keywords provided by Dallas VA Medical Center:
Esophagitis
Reflux esophagitis
Gastroesophageal reflux disease
Acid
Inflammation
Esophagus
Cytokines
Esophageal squamous cell
Reflux
Squamous epithelium

Additional relevant MeSH terms:
Esophagitis
Esophagitis, Peptic
Gastroesophageal Reflux
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Peptic Ulcer
Esophageal Motility Disorders
Deglutition Disorders

ClinicalTrials.gov processed this record on April 17, 2014