Eosinophilic Esophagitis (EoE), Functional Dyspepsia, Gastroesophageal Reflux Disease (GERD)
Conditions
Keywords
GERD, EGD, pH testing, eosinophilic esophagitis, impedance testing
Brief summary
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
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.
Interventions
DIAGNOSTIC_TESTStandard of Care esophagogastroduodenoscopy (EGD) with measurement of mucosal impedance
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Vanderbilt University Medical Center
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Years to 18 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients with GERD and/or Eosinophilic Esophagitis(EoE) | 5 minutes | 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. |
| Mucosal impedance values correspond with histopathologic diagnosis in patients with EoE | 5 minutes | — |
Countries
United States
Outcome results
None listed