Biology in Patients With Reflux Esophagitis

GERD Clinical Trial

— BENCH  

Official title:

Biology in Patients With Reflux Esophagitis and Mucosal Impedance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01194323
• Other study ID #: BENCH
• Status: Completed
• Phase: N/A
• First received: August 31, 2010
• Last updated: March 31, 2017
• Start date: November 2010
• Est. completion date: December 2012

Study information

• Verified date: March 2017
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria (GERD Cases):

• Male or female

• Ages 18 years or older

• Undergoing EGD as standard of care at Vanderbilt's Digestive Diseases Center

• Esophageal erosion detected at EGD

• Abnormal pH monitoring

Inclusion Criteria (Controls):

• Male or female

• Ages 18 years or older

• Undergoing EGD as standard of care at Vanderbilt's Digestive Diseases Center

• No complaints or history o heartburn or acid regurgitation

• No erosion at EGD

• Normal pH monitoring

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

Related Conditions & MeSH terms

• Esophagitis
• Esophagitis, Peptic
• GERD

Locations

Country	Name	City	State
United States	Vanderbilt University Digestive Diseases Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Chronic exposure
Primary	Change in local impedance of the esophageal mucosa	We are assessing if acid exposure affects local impedance of the mucosa	Chronic exposure