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OpenTrials
Active, Not Recruiting

NCT Number: NCT01921686

Morphological Markers of Gastroesophageal Reflux Disease (GERD)

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Sample collection and Questionnaire

Other

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.

Primary outcomes

  1. TEM analysis

    Time frame: at time of sample collection

    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.

Secondary outcomes

  1. pH monitoring

    Time frame: 24 hours

    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

Other outcomes

  1. Immunoblotting

    Time frame: At time of sample collection

    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.

Sponsors and collaborators

Lead sponsor

Baylor College of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2026
First posted
Aug 13, 2013
Registry last updated
Jul 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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