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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gastroesophageal Reflux Disease (GERD) | History of troublesome symptoms (e.g. heartburn, chest pain, acid regurgitation) secondary to reflux of gastric contents at least three times per week AND, At least one of the following:
|
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| Eosinophilic Esophagitis (EoE) |
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| |
| Control | Patients with no history of troublesome esophageal symptoms or esophageal disease AND normal esophagoscopy (for example, patients undergoing evaluation for chronic abdominal pain, inflammatory bowel disease, celiac disease). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sample collection and Questionnaire | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | at time of sample collection |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Immunoblotting | Evaluate the correlation between mean Dilated Intercellular Spaces diameter and injury to the Intercellular Junctional Complex (IJC) through immunoblotting-based assessment of cleaved versus intact e-cadherin. | At time of sample collection |
Inclusion Criteria for GERD or EoE Subjects:
Inclusion Criteria for Control Subjects:
Exclusion Criteria for GERD or EoE Subjects:
Exclusion Criteria for Control Subjects:
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Children between the ages of 8-18 years scheduled for endoscopy for clinical indication.
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| Name | Affiliation | Role |
|---|---|---|
| Eric H Chiou, MD | Baylor College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Texas Children's Hospital | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| Physician Profile | View source |
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| ID | Term |
|---|---|
| D057765 | Eosinophilic Esophagitis |
| D005764 | Gastroesophageal Reflux |
| D005512 | Food Hypersensitivity |
| D003680 | Deglutition Disorders |
| ID | Term |
|---|---|
| D004941 | Esophagitis |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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Three esophageal biopsy samples
|
| D005759 |
| Gastroenteritis |
| D004802 | Eosinophilia |
| D007960 | Leukocyte Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D015154 | Esophageal Motility Disorders |
| D010608 | Pharyngeal Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |