Mucosal Impedance in Pediatric Population

Functional Dyspepsia Clinical Trial

Official title:

Assessment of Esophageal Epithelium Integrity With Mucosal Impedance in Pediatric Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02320981
• Other study ID #: IRB 140987
• Secondary ID: T32DK007673-21
• Status: Completed
• Phase: N/A
• First received: July 14, 2014
• Last updated: April 27, 2017
• Start date: August 2014
• Est. completion date: September 2016

Study information

• Verified date: April 2017
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 127
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 18 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Diagnostic Test:
• Standard of Care esophagogastroduodenoscopy (EGD) with measurement of mucosal impedance

Locations

Country	Name	City	State
United States	Vanderbilt Children's Hospital	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Mucosal impedance values correspond with histopathologic diagnosis in patients with EoE		5 minutes