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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01733810

Enrollment

Registered

2012-11-27

Start date

2013-02-01

Completion date

2019-07-31

Last updated

2020-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophagitis, Gastroesophageal Reflux Disease, Reflux Esophagitis

Keywords

Esophagitis, Reflux esophagitis, Gastroesophageal reflux disease, Acid, Inflammation, Esophagus, Cytokines, Esophageal squamous cell, Reflux, Squamous epithelium

Brief summary

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

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

OTHERCessation 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026