Can We Predict Who Has Gastroesophageal Reflux Disease (GERD)?

January 19, 2016 updated by: Michael Vaezi, Vanderbilt University

Can We Predict Who Has GERD? Systematic Evaluation of Role of pH Monitoring and the Specific Physiologic pH Parameters in Defining GERD, Bravo, Impedence and SISAP

Gastroesophageal reflux disease (GERD) is currently defined as "a condition which develops when the reflux of stomach contents causes troublesome symptoms and/or complications". Doctors often diagnose and treat GERD based on symptoms of heartburn and regurgitation. In recent years, the prevalence of partial or non-response to Proton Pump Inhibitors (PPI) has increased resulting in diagnostic testing with esophagogastroduodenoscopy (EGD) or ambulatory pH monitoring. Most patients do not have endoscopic evidence for reflux. Thus, in this group pH monitoring has emerged as an important physiologic test to determine the degree of esophageal acid exposure and to assess the association between patients' persistent symptoms and acid reflux events. The aims of this study are to assess the sensitivity and specificity of symptom associated indices and determine the best parameter for predicting GERD from a list of conventional pH measurement findings.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

254

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center GI Outpatient Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Adult subjects presenting to Vanderbilt University Medical Center Gastroenterology outpatient clinic with symptoms consistent with gastroesophageal reflux disease (GERD)

Description

Inclusion Criteria:

  • Male and female subjects ages 18 or older
  • Presenting to the Vanderbilt GI outpatient clinic with symptoms of GERD
  • Undergoing upper endoscopy and wireless pH monitoring (standard of care)
  • Erosive disease: presence of esophageal mucosal injuries documented
  • Non-erosive disease: normal esophagogastroduodenoscopy (EGD) with symptoms
  • Control group: normal subjects without symptoms of GERD

Exclusion Criteria:

  • Anti-reflux therapy within 7 days prior to the pH study
  • Previous neck, esophagus, or stomach surgery
  • Major motility disorders
  • Previous neck, esophagus, or stomach cancer or radiations

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Gastroesophageal Reflux Disease (GERD) Cases

Erosive disease - presence of esophageal mucosal injuries documented endoscopically.

Non-erosive disease - normal esophagogastroduodenoscopy with symptoms
Control Group
normal subjects without symptoms of gastroesophageal reflux disease (GERD)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symptom Index (SI) and Symptom Associated Probability (SAP)
Time Frame: Following esophagogastroduodenoscopy (EGD) and 48-hr-wireless pH monitoring
Assess the sensitivity and specificity of symptom association indices (SI and SAP)regarding gastroesophageal reflux disease (GERD)
Following esophagogastroduodenoscopy (EGD) and 48-hr-wireless pH monitoring
Predicting gastroesophageal reflux disease (GERD)
Time Frame: Following esophagogastroduodenoscopy (EGD) and 48-hr-wireless pH monitoring
Determine the best parameter for predicting gastroesophageal reflux disease (GERD) from a list of conventional pH measurement findings.
Following esophagogastroduodenoscopy (EGD) and 48-hr-wireless pH monitoring

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

September 13, 2010

First Submitted That Met QC Criteria

September 16, 2010

First Posted (Estimate)

September 17, 2010

Study Record Updates

Last Update Posted (Estimate)

January 20, 2016

Last Update Submitted That Met QC Criteria

January 19, 2016

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GERD SISAP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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