Biology in Patients With Reflux Esophagitis

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.

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Key information

Conditions

GERD Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Vanderbilt University Digestive Diseases Center

Nashville, Tennessee, 37232, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Change in gene and protein expression due to acid exposure in the esophagus

Time frame: Chronic exposure

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

We are assessing if acid exposure affects local impedance of the mucosa

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Official study title

Biology in Patients With Reflux Esophagitis and Mucosal Impedance

Acronym: BENCH

Important dates

Study start: 2010
Primary completion: 2012
Study completion: 2012
First posted: Sep 2, 2010
Registry last updated: Apr 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed