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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Esophagitis, Reflux Esophagitis, Gastroesophageal Reflux Disease

Intervention / Treatment
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* Other: Cessation of Acid Suppressing Medications


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Reflux Patients<br>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<br>* Acid-suppressing medications are stopped for all participants the day after baseline assessment. Subsequent evaluations performed while participant is not on acid-suppressing medications.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in esophageal inflammation from baseline to 14 days | inflammation of the squamous esophageal mucosa will be measured at baseline and at 14 days | day 0 and day 14 | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Esophagitis, Reflux esophagitis, Gastroesophageal reflux disease, Acid, Inflammation, Esophagus, Cytokines, Esophageal squamous cell, Reflux, Squamous epithelium