Mucosal Impedance in Pediatric Population

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 who do not have GERD or EE.

Study Overview

• Status: Completed
• Conditions: Functional Dyspepsia; Gastroesophageal Reflux Disease (GERD); Eosinophilic Esophagitis (EoE)
• Intervention / Treatment: Diagnostic test: Standard of Care esophagogastroduodenoscopy (EGD) with measurement of mucosal impedance

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.

• Study Type: Observational
• Enrollment (Actual): 127

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
EGD with Biopsy; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Mary Allyson Lowry, MD, Vanderbilt University Medical Center; Principal Investigator: Sari Acra, MD, Vanderbilt University Medical Center

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: July 14, 2014
• First Submitted That Met QC Criteria: December 15, 2014
• First Posted (Estimate): December 19, 2014

Study Record Updates

• Last Update Posted (Actual): May 1, 2017
• Last Update Submitted That Met QC Criteria: April 27, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: GERD; EGD; eosinophilic esophagitis; pH testing; impedance testing
• Additional Relevant MeSH Terms: Digestive System Diseases; Immune System Diseases; Hypersensitivity, Immediate; Hematologic Diseases; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Gastroenteritis; Hypersensitivity; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Leukocyte Disorders; Eosinophilia; Dyspepsia; Gastroesophageal Reflux; Eosinophilic Esophagitis; Esophagitis
• Other Study ID Numbers: IRB 140987; T32DK007673-21 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No