Clinical trial NCT02320981: Mucosal Impedance in Pediatric Population
Official title: Assessment of Esophageal Epithelium Integrity With Mucosal Impedance in Pediatric Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastroesophageal Reflux Disease (GERD)
Eosinophilic Esophagitis (EoE)
Functional Dyspepsia
Keywords: GERD
EGD
pH testing
eosinophilic esophagitis
impedance testing
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2014-12-19
Enrollment: 127
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pediatric patients of our Vanderbilt Pediatric Gastroenterology Clinic undergoing routine evaluation of dyspepsia with endoscopy that meet the inclusion/exclusion criteria as defined above.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Patients with GERD and/or Eosinophilic Esophagitis(EoE)
timeFrame: 5 minutes
measure: Mucosal impedance values correspond with histopathologic diagnosis in patients with EoE
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt Children's Hospital
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Mary Allyson Lowry, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Vanderbilt University Medical Center
name: Sari Acra, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Vanderbilt University Medical Center
name: Michael Vaezi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: