Morphological Markers of Gastroesophageal Reflux Disease (GERD)

N/AActive Not RecruitingNCT01921686

Baylor College of Medicine54 enrolled

Overview

The purpose of this project is to learn more about a new and promising way to diagnose acid reflux disease using a very high-powered microscope. This special microscope provides much finer detail than typical microscopes previously used for diagnosing reflux, and may help doctors to better identify children with acid reflux.

This will be a prospective case control study. Children between the ages of 8 and 18 with suspected gastroesophageal reflux disease (GERD) or eosinophilic esophagitis (EoE) based on symptom criteria and who have been scheduled for esophagogastroduodenoscopy (EGD) by their primary gastroenterologist will be recruited. Children who do not have any history of esophageal disease or esophageal symptoms and are scheduled for EGD for other clinical indications (e.g. rule out celiac disease) by their primary gastroenterologist will be recruited and act as controls. Control subjects will also be given the opportunity to undergo esophageal MII-pH monitoring as part of their medical evaluation, but will not be excluded from analysis should they opt out of this part of the study. For all subjects, in addition to endoscopic evaluation, biopsies of the distal esophagus will be obtained for routine light microscopy (standard histology sample) as well as Transmission Electron Microscopy (TEM) analysis to determine the presence and magnitude of dilated intercellular spaces (DIS), and immunoblotting for e-cadherin cleavage

Study Type

OBSERVATIONAL

Enrollment

Conditions

Eosinophilic Esophagitis Gastroesophageal Reflux Disease

Interventions

Sample collection and QuestionnaireOTHER

This is an observational biospecimen collection and questionnaire study. The subjects will be asked to complete a symptom questionnaire at screening visit. In addition, 3 esophageal biopsy samples will be taken to conduct laboratory analyses.

Eligibility

Sex: ALLMin age: 8 YearsMax age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria for GERD or EoE Subjects: * Children between the ages of 8-18 years * Suspected diagnosis of GERD or EoE based on symptom criteria * Able to tolerate upper endoscopy examination with biopsies Inclusion Criteria for Control Subjects: * Children between the ages of 8-18 * Scheduled for EGD for clinical indications * No history of esophageal disease of esophageal symptoms * Able to tolerate upper endoscopy examination with biopsies Exclusion Criteria for GERD or EoE Subjects: * History of Barrett's esophagus * Previous esophageal or gastric surgery * History of congenital defect/malformation of the esophagus * Diagnosis of Crohn disease Exclusion Criteria for Control Subjects: * Symptoms of GERD or EoE (including heartburn, regurgitation, difficulty swallowing, painful swallowing).

Locations (1)

Texas Children's Hospital

Houston, Texas, United States

Outcomes

Primary Outcomes

TEM analysis

Using transmission electron microscopy (TEM), compare mean Dilated Intercellular Space diameter of esophageal epithelium in children with GERD to children with Eosinophilic Esophagitis and normal controls.

Time frame: at time of sample collection

Secondary Outcomes

pH monitoring

Evaluate the correlation between mean Dilated Intercellular Spaces diameter and quantitative reflux parameters determined by 24-hour esophageal multichannel intraluminal impedance-pH (MII-pH) monitoring

Time frame: 24 hours

Data from ClinicalTrials.gov

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