Morphological Markers of Gastroesophageal Reflux Disease (GERD)

NCT ID: NCT01921686

Last Updated: 2025-07-28

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 54 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2026-12-31

Brief 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.

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

Conditions

Eosinophilic Esophagitis; Gastroesophageal Reflux Disease

Study Design

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

Study Groups

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)

Sample collection and Questionnaire

Intervention Type: 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.

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.

Sample collection and Questionnaire

Intervention Type: 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.

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).

Sample collection and Questionnaire

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

• 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

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

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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Baylor College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Eric Chiou

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eric H Chiou, MD

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Locations

Texas Children's Hospital

Houston, Texas, United States

Countries

United States

Related Links

https://www.texaschildrens.org/find-a-doctor/eric-h-chiou-md

Physician Profile

Other Identifiers

H-28604

Identifier Type: -

Identifier Source: org_study_id