Clinical trial NCT01921686: Morphological Markers of Gastroesophageal Reflux Disease (GERD)
Official title: Dilation of Intercellular Spaces as Morphological Markers of Gastroesophageal Reflux Disease (GERD)In Children
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Eosinophilic Esophagitis
Gastroesophageal Reflux Disease
Keywords: Eosinophil
Reflux
Esophagus
Food allergy
Trouble Swallowing
Pediatrics
Healthy Volunteers
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2013-08-13
Enrollment: 54
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children between the ages of 8-18 years scheduled for endoscopy for clinical indication.

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

Eligibility criteria: 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).

Primary outcomes:
measure: TEM analysis
timeFrame: at time of sample collection
Secondary outcomes:
measure: pH monitoring
timeFrame: 24 hours
Other outcomes:
measure: Immunoblotting
timeFrame: At time of sample collection
Locations:
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Eric H Chiou, MD
role: PRINCIPAL_INVESTIGATOR
References: