Morphological Markers of Gastroesophageal Reflux Disease (GERD)

Gastroesophageal Reflux Disease Clinical Trial

Official title:

Dilation of Intercellular Spaces as Morphological Markers of Gastroesophageal Reflux Disease (GERD)In Children

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01921686
• Other study ID #: H-28604
• Status: Active, not recruiting
• Start date: March 2013
• Est. completion date: February 2025

Study information

• Verified date: March 2024
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this project is to learn more about a new and promising way to diagnose acid reflux disease using a very high-powered microscope. This special microscope provides much finer detail than typical microscopes previously used for diagnosing reflux, and may help doctors to better identify children with acid reflux.

Description:

This will be a prospective case control study. Children between the ages of 8 and 18 with suspected gastroesophageal reflux disease (GERD) or eosinophilic esophagitis (EoE) based on symptom criteria and who have been scheduled for esophagogastroduodenoscopy (EGD) by their primary gastroenterologist will be recruited. Children who do not have any history of esophageal disease or esophageal symptoms and are scheduled for EGD for other clinical indications (e.g. rule out celiac disease) by their primary gastroenterologist will be recruited and act as controls. Control subjects will also be given the opportunity to undergo esophageal MII-pH monitoring as part of their medical evaluation, but will not be excluded from analysis should they opt out of this part of the study. For all subjects, in addition to endoscopic evaluation, biopsies of the distal esophagus will be obtained for routine light microscopy (standard histology sample) as well as Transmission Electron Microscopy (TEM) analysis to determine the presence and magnitude of dilated intercellular spaces (DIS), and immunoblotting for e-cadherin cleavage

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 54
• Est. completion date: February 2025
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 18 Years

Eligibility

Inclusion Criteria for GERD or EoE Subjects:

• Children between the ages of 8-18 years
• Suspected diagnosis of GERD or EoE based on symptom criteria
• Able to tolerate upper endoscopy examination with biopsies

Inclusion Criteria for Control Subjects:

• Children between the ages of 8-18
• Scheduled for EGD for clinical indications
• No history of esophageal disease of esophageal symptoms
• Able to tolerate upper endoscopy examination with biopsies

Exclusion Criteria for GERD or EoE Subjects:

• History of Barrett's esophagus
• Previous esophageal or gastric surgery
• History of congenital defect/malformation of the esophagus
• Diagnosis of Crohn disease

Exclusion Criteria for Control Subjects:

• Symptoms of GERD or EoE (including heartburn, regurgitation, difficulty swallowing, painful swallowing).

Related Conditions & MeSH terms

• Eosinophilic Esophagitis
• Esophagitis
• Esophagitis, Peptic
• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease

Intervention

Other:
• Sample collection and Questionnaire
This is an observational biospecimen collection and questionnaire study. The subjects will be asked to complete a symptom questionnaire at screening visit. In addition, 3 esophageal biopsy samples will be taken to conduct laboratory analyses.

Locations

Country	Name	City	State
United States	Texas Children's Hospital	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Baylor College of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Immunoblotting	Evaluate the correlation between mean Dilated Intercellular Spaces diameter and injury to the Intercellular Junctional Complex (IJC) through immunoblotting-based assessment of cleaved versus intact e-cadherin.	At time of sample collection
Primary	TEM analysis	Using transmission electron microscopy (TEM), compare mean Dilated Intercellular Space diameter of esophageal epithelium in children with GERD to children with Eosinophilic Esophagitis and normal controls.	at time of sample collection
Secondary	pH monitoring	Evaluate the correlation between mean Dilated Intercellular Spaces diameter and quantitative reflux parameters determined by 24-hour esophageal multichannel intraluminal impedance-pH (MII-pH) monitoring	24 hours

External Links

•   Physician Profile