Overview

This trial is active, not recruiting.

Conditions esophagitis, reflux esophagitis, gastroesophageal reflux disease
Treatment cessation of acid suppressing medications
Sponsor Dallas VA Medical Center
Collaborator National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Start date February 2013
End date January 2017
Trial size 15 participants
Trial identifier NCT01733810, 2R01DK063621-11, R01DK063621

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose basic science
Arm
(Experimental)
Patients with reflux and a prior history of reflux esophagitis are being enrolled. The intervention is cessation of acid-suppressing medications.
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.

Primary Outcomes

Measure
change in esophageal inflammation from baseline to 14 days
time frame: day 0 and day 14

Secondary Outcomes

Measure
change in HIF-2a levels from baseline to 14 days
time frame: day 0 and day 14

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title The Role of HIF-2a in the Pathogenesis of Reflux Esophagitis
Principal investigator Stuart J Spechler, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Dallas VA Medical Center.