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Completed

NCT Number: NCT01733810

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

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.

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Key information

Conditions

Esophagitis Deglutition Disorders Digestive System Diseases Duodenal Diseases Esophageal Diseases Esophageal Motility Disorders Esophagitis, Peptic Gastroenteritis Gastroesophageal Reflux Gastroesophageal Reflux Disease Gastrointestinal Diseases Heartburn Inflammation Intestinal Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Peptic Ulcer Reflux Esophagitis Signs and Symptoms Signs and Symptoms, Digestive Stomach Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dallas VA Medical Center

Dallas, Texas, 75216, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cessation of Acid Suppressing Medications

Other

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

  1. 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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Dallas VA Medical Center

Fed

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2019
First posted
Nov 27, 2012
Registry last updated
Feb 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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