Biology in Patients With Reflux Esophagitis

Completed

• Conditions: GERD

• Registration Number: NCT01194323
• Lead Sponsor: Vanderbilt University Medical Center

Brief Summary

GERD is a common condition in the western world. In most cases, the diagnostic is established by good response to empiric proton pump inhibitor (PPI) therapy. When the patient symptoms are refractory to therapy, multiple invasive tests are available. The results of those tests (EGD, manometry, Ph monitoring and impedance) are clues that the physician use together to establish the diagnostic. No test however can be use alone because of their poor specificity and sensitivity. Recently, microscopy has been used to detect dilated intercellular space in between distal esophageal cells tissue; unfortunately this marker again failed to diagnose GERD.

In search of more sensitive and specific markers of GERD, we propose to assess if acid exposure affects: 1) gene and proteins expression in the esophageal/post-cricoid area tissue; and 2) local impedance of the mucosa. The secondary aim of this proposal is to determine if correlation exists between the two approaches.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-08-31
• Study First Submitted QC: 2010-08-31
• Study First Posted: 2010-09-02
• Study Start: 2010-11
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-31
• Last Update Posted: 2017-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

Not provided

Exclusion Criteria

• Less than 18 years of age
• Unable to provide informed consent
• Use of acid suppressive therapy within last 14 days
• known history of Barrett's esophagus, gastric surgery, alcoholism, significant motility condition
• contraindications to biopsy such as taking anticoagulants other than aspirin (coumadin, plavix) or allergies to local anesthetic

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in local impedance of the esophageal mucosa	Chronic exposure	We are assessing if acid exposure affects local impedance of the mucosa
Change in gene and protein expression due to acid exposure in the esophagus	Chronic exposure	We are assessing if acid exposure affects gene and protein expression in the esophageal/post-cricoid area tissue

Trial Locations

Locations (1)

Vanderbilt University Digestive Diseases Center; 🇺🇸 Nashville, Tennessee, United States