Morphological Markers of Gastroesophageal Reflux Disease (GERD)
This trial is active, not recruiting.
|Conditions||eosinophilic esophagitis, gastroesophageal reflux disease|
|Treatment||sample collection and questionnaire|
|Sponsor||Baylor College of Medicine|
|Start date||March 2013|
|End date||September 2014|
|Trial size||54 participants|
|Trial identifier||NCT01921686, H-28604|
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.
|Observational model||case control|
time frame: at time of sample collection
time frame: 24 hours
Male or female participants from 8 years up to 18 years old.
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).
|Official title||Dilation of Intercellular Spaces as Morphological Markers of Gastroesophageal Reflux Disease (GERD)In Children|
|Principal investigator||Eric H Chiou, MD|
|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|
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