Biology in Patients With Reflux Esophagitis (BENCH)
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.
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Biology in Patients With Reflux Esophagitis and Mucosal Impedance|
- Change in gene and protein expression due to acid exposure in the esophagus [ Time Frame: Chronic exposure ] [ Designated as safety issue: No ]We are assessing if acid exposure affects gene and protein expression in the esophageal/post-cricoid area tissue
- Change in local impedance of the esophageal mucosa [ Time Frame: Chronic exposure ] [ Designated as safety issue: No ]We are assessing if acid exposure affects local impedance of the mucosa
Biospecimen Retention: Samples With DNA
Total RNA and proteins will be extracted from de-identified samples. Genes' and proteins' expression will be processed and analyzed at Vanderbilt Core Facilities.
|Study Start Date:||November 2010|
|Estimated Study Completion Date:||June 2015|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
No complaints or history of heartburn or acid regurgitation; no erosion at EGD; and normal pH monitoring
Patients with esophageal erosion at EGD and abnormal pH monitoring.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01194323
|United States, Tennessee|
|Vanderbilt University Digestive Diseases Center|
|Nashville, Tennessee, United States, 37232|
|Principal Investigator:||Michael Vaezi, MD, PhD||Vanderbilt University|