An observational study in GERD, sponsored by Vanderbilt University Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-04-04.
Sponsored by Vanderbilt University Medical Center · Observational
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.
322 studies on the registry are indexed under Esophagitis; 37 are open to participants now.
This study's enrollment of 75 is below the median of 100 across 91 observational studies indexed under Esophagitis.
Browse Esophagitis studies →Vanderbilt University Medical Center is the lead sponsor of 824 studies on the registry; 164 are open to participants now.
Of its 122 completed or terminated interventional studies of FDA-regulated products, 91 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Male and female volunteers ages 18 years and older; able to give informed consent; no use of acid suppressive therapy within 14 days prior to procedure; no history of Barret's esophagus, gastric surgery, alcoholism, or significant motility condition; no contraindications to biopsy, including taking anticoagulants or allergies to local anesthetic.
Inclusion Criteria (GERD Cases):
Inclusion Criteria (Controls):
Exclusion Criteria:
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.
Change in gene and protein expression due to acid exposure in the esophagus
We are assessing if acid exposure affects gene and protein expression in the esophageal/post-cricoid area tissue
Time frame: Chronic exposure
Change in local impedance of the esophageal mucosa
We are assessing if acid exposure affects local impedance of the mucosa
Time frame: Chronic exposure
Plan to share: No
This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
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Vanderbilt University Medical Center