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

Gastroesophageal Reflux Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01733810
• Other study ID #: 2R01DK063621-11
• Secondary ID: R01DK063621
• Status: Completed
• Phase: N/A
• Start date: February 1, 2013
• Est. completion date: July 31, 2019

Study information

• Verified date: February 2020
• Source: Dallas VA Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: July 31, 2019
• Est. primary completion date: July 31, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Esophagitis
• Esophagitis, Peptic
• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease
• Reflux Esophagitis

Intervention

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.

Locations

Country	Name	City	State
United States	Dallas VA Medical Center	Dallas	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Dallas VA Medical Center	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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