Mucosal Impedance in Pediatric Population

Study Overview
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Brief Summary
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Our hypothesis is that patients with GERD and/or Eosinophilic Esophagitis (EE) have lower esophageal impedance measurements when compared to patients who do not have GERD or EE.

Detailed Description
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The overall goal of this project is to develop and assess a novel, inexpensive, minimally invasive technology to detect mucosal damage based on mucosal conductivity changes in the pediatric population. The study is based on preliminary work between Sandhill Scientific, Inc. and our adult gastroenterology department. They have collaborated to create a novel, minimally invasive Mucosal Impedance (MI) test (proprietary technology) based on animal studies which have shown esophageal tissue exposed to acidic and weakly acidic injurious agents causes dilation of intercellular spaces and loss of tight junctions along the squamous epithelial lining of the esophagus and results in measurable decreased baseline impedance.9 Adult studies have confirmed the correlation between decreased impedance and diseased tissue, however this has not been studied in children. We hypothesize that pediatric patients with histologic damage seen in GERD and EoE will have mucosal changes resulting in decreased electrical impedance compared to those with normal histology. We propose that this technology will accurately and reliably measure the mucosal consequence of chronic esophageal exposure to injurious gastroduodenal agents or food allergens. Thus, this test would serve as a minimally invasive screening tool for GERD and EoE prior to endoscopy, and allow longitudinal monitoring of mucosal response to therapy.

Official Title
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Assessment of Esophageal Epithelium Integrity With Mucosal Impedance in Pediatric Patients

Conditions
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Gastroesophageal Reflux Disease (GERD), Eosinophilic Esophagitis (EoE), Functional Dyspepsia

Intervention / Treatment
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* Diagnostic Test: Standard of Care esophagogastroduodenoscopy (EGD) with measurement of mucosal impedance


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients between 1 year and 18 years of age Patients who are undergoing standard of care upper endoscopy and biopsy for complaints of dyspepsia Exclusion Criteria: Families unable to give informed consent/assent; Patients with other active comorbid conditions including cardiac disease, pulmonary disease (excluding asthma), significant motility conditions

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| EGD with Biopsy<br>Pediatric patients scheduled for standard of care EGD with biopsy also received measurement of mucosal impedance | Diagnostic Test: Standard of Care esophagogastroduodenoscopy (EGD) with measurement of mucosal impedance<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients with GERD and/or Eosinophilic Esophagitis(EoE) | Mucosal impedance will be obtained during standard of care endoscopy and results will be available immediately. For those patients who may be undergoing ph monitoring as standard of care, those data will be compared to the mucosal impedance values obtained at bedside. | 5 minutes | 
| Mucosal impedance values correspond with histopathologic diagnosis in patients with EoE |  | 5 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GERD, EGD, pH testing, eosinophilic esophagitis, impedance testing