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

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.

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Key information

Conditions

Gastroesophageal Reflux Disease 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 Medical Center GI Outpatient Clinic

Nashville, Tennessee, 37232, United States

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Primary outcomes

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)
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.

Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Registry information

Official study title

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

Important dates

Study start: 2010
Primary completion: 2013
Study completion: 2015
First posted: Sep 17, 2010
Registry last updated: Jan 20, 2016

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