Morphological Markers of Gastroesophageal Reflux Disease (GERD)

March 20, 2024 updated by: Eric Chiou, Baylor College of Medicine

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed 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

Study Type

Observational

Enrollment (Actual)

54

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Texas Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Children between the ages of 8-18 years scheduled for endoscopy for clinical indication.

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Gastroesophageal Reflux Disease (GERD)

History of troublesome symptoms (e.g. heartburn, chest pain, acid regurgitation) secondary to reflux of gastric contents at least three times per week

AND, At least one of the following:

  • Mucosal breaks on endoscopy (at least Grade-A esophagitis based on Los Angeles classification)
  • Abnormal pH index (pH less than 4 for greater than 6% of study)
  • Abnormal MII-pH (greater than 73 episodes of total reflux per 24 hours)
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.
Eosinophilic Esophagitis (EoE)
  • History of troublesome esophageal symptoms (e.g. dysphagia, food impaction, vomiting, upper abdominal or chest pain)
  • Greater than or equal to 15 eosinophils in at least one high powered field (HPF) from distal OR proximal esophageal biopsy
  • Lack of histological response to 6-8 weeks of high dose Proton Pump Inhibitor (PPI) OR negative pH probe (pH less than 4 for less than 6% of study). Subjects with greater than 15 eosinophils/HPF and abnormal pH results may have an overlap syndrome and will be excluded from the primary analysis.
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.
Control
Patients with no history of troublesome esophageal symptoms or esophageal disease AND normal esophagoscopy (for example, patients undergoing evaluation for chronic abdominal pain, inflammatory bowel disease, celiac disease).
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at time of sample collection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24 hours

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At time of sample collection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baylor College of Medicine

Investigators

  • Principal Investigator: Eric H Chiou, MD, Baylor College of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

September 1, 2014

Study Completion (Estimated)

February 1, 2025

Study Registration Dates

First Submitted

August 9, 2013

First Submitted That Met QC Criteria

August 9, 2013

First Posted (Estimated)

August 13, 2013

Study Record Updates

Last Update Posted (Actual)

March 21, 2024

Last Update Submitted That Met QC Criteria

March 20, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-28604

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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