Mucosal Impedance in Pediatric Population

NCT ID: NCT02320981

Last Updated: 2017-05-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 127 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2016-09-30

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.

Conditions

Gastroesophageal Reflux Disease (GERD); Eosinophilic Esophagitis (EoE); Functional Dyspepsia

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

EGD with Biopsy

Pediatric patients scheduled for standard of care EGD with biopsy also received measurement of mucosal impedance

Standard of Care esophagogastroduodenoscopy (EGD) with measurement of mucosal impedance

Intervention Type: DIAGNOSTIC_TEST

Interventions

Standard of Care esophagogastroduodenoscopy (EGD) with measurement of mucosal impedance

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Michael Vaezi

Co-Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mary Allyson Lowry, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Sari Acra, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Michael Vaezi, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

Vanderbilt Children's Hospital

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

T32DK007673-21

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB 140987

Identifier Type: -

Identifier Source: org_study_id