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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Basic Science
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 31, 2015

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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • Experimental: Reflux Patients
    • Patients with reflux and a prior history of reflux esophagitis are being enrolled. The intervention is cessation of acid-suppressing medications.

Clinical Trial Outcome Measures

Primary Measures

  • change in esophageal inflammation from baseline to 14 days
    • Time Frame: day 0 and day 14
    • inflammation of the squamous esophageal mucosa will be measured at baseline and at 14 days

Secondary Measures

  • change in HIF-2a levels from baseline to 14 days
    • Time Frame: day 0 and day 14
    • Amount of HIF-2a present will be measured at baseline and at 14 days

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Dallas VA Medical Center
  • Collaborator
    • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • Provider of Information About this Clinical Study
    • Principal Investigator: Stuart Spechler, Professor of Medicine – Dallas VA Medical Center
  • Overall Official(s)
    • Stuart J Spechler, MD, Principal Investigator, Dallas VA Medical Center

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