We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01733810
First Posted: November 27, 2012
Last Update Posted: August 2, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Stuart Spechler, Dallas VA Medical Center
  Purpose
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.

Condition Intervention
Esophagitis Reflux Esophagitis Gastroesophageal Reflux Disease Other: Cessation of Acid Suppressing Medications

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Role of HIF-2a in the Pathogenesis of Reflux Esophagitis

Resource links provided by NLM:


Further study details as provided by Stuart Spechler, Dallas VA Medical Center:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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


Estimated Enrollment: 15
Study Start Date: February 2013
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Reflux Patients
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
Acid-suppressing medications are stopped for all participants the day after baseline assessment. Subsequent evaluations performed while participant is not on acid-suppressing medications.

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01733810


Locations
United States, Texas
Dallas VA Medical Center
Dallas, Texas, United States, 75216
Sponsors and Collaborators
Dallas VA Medical Center
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Stuart J Spechler, MD Dallas VA Medical Center
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Stuart Spechler, Professor of Medicine, Dallas VA Medical Center
ClinicalTrials.gov Identifier: NCT01733810     History of Changes
Other Study ID Numbers: 2R01DK063621-11 ( U.S. NIH Grant/Contract )
R01DK063621 ( U.S. NIH Grant/Contract )
First Submitted: November 16, 2012
First Posted: November 27, 2012
Last Update Posted: August 2, 2016
Last Verified: August 2016

Keywords provided by Stuart Spechler, Dallas VA Medical Center:
Esophagitis
Reflux esophagitis
Gastroesophageal reflux disease
Acid
Inflammation
Esophagus
Cytokines
Esophageal squamous cell
Reflux
Squamous epithelium

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophagitis
Esophagitis, Peptic
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Stomach Diseases


To Top