Mucosal Impedance in Pediatric Population



Status:Recruiting
Conditions:Gastroesophageal Reflux Disease , Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:1 - 18
Updated:8/12/2016
Start Date:August 2014
End Date:February 2017
Contact:Mary Allyson Lowry, MD
Email:mary.a.lowry@vanderbilt.edu

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Assessment of Esophageal Epithelium Integrity With Mucosal Impedance in Pediatric Patients

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

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.

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
We found this trial at
1
site
2200 Children's Way
Nashville, Tennessee 37232
(615) 936-1000
Principal Investigator: Mary Allyson Lowry, MD
Vanderbilt Children's Hospital Monroe Carell Jr. Children's Hospital at Vanderbilt is one of the nation's...
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mi
from
Nashville, TN
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