Eosinophilic Esophagitis, Gastroesophageal Reflux Disease
Conditions
Keywords
Eosinophil, Reflux, Esophagus, Food allergy, Trouble Swallowing, Pediatrics, Healthy Volunteers
Brief summary
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.
Detailed description
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
Interventions
OTHERSample collection and Questionnaire
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.
Sponsors
Baylor College of Medicine
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
8 Years to 18 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| TEM analysis | at time of sample collection | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| pH monitoring | 24 hours | 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATOREric H Chiou, MD
Baylor College of Medicine
Outcome results
None listed