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Biology in Patients With Reflux Esophagitis (BENCH)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01194323
First Posted: September 2, 2010
Last Update Posted: April 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Michael Vaezi, Vanderbilt University Medical Center
  Purpose

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.


Condition
GERD

Study Type: Observational
Study Design: Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Biology in Patients With Reflux Esophagitis and Mucosal Impedance

Further study details as provided by Michael Vaezi, Vanderbilt University Medical Center:

Primary Outcome Measures:
  • 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


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.

Enrollment: 75
Study Start Date: November 2010
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Controls
No complaints or history of heartburn or acid regurgitation; no erosion at EGD; and normal pH monitoring
GERD Cases
Patients with esophageal erosion at EGD and abnormal pH monitoring.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01194323


Locations
United States, Tennessee
Vanderbilt University Digestive Diseases Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University Medical Center
Investigators
Principal Investigator: Michael Vaezi, MD, PhD Vanderbilt University Medical Center
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Michael Vaezi, Medical Director, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT01194323     History of Changes
Other Study ID Numbers: BENCH
First Submitted: August 31, 2010
First Posted: September 2, 2010
Last Update Posted: April 4, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Michael Vaezi, Vanderbilt University Medical Center:
esophageal erosion
abnormal pH monitoring

Additional relevant MeSH terms:
Esophagitis
Esophagitis, Peptic
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Stomach Diseases