Morphological Markers of Gastroesophageal Reflux Disease (GERD)

NCT01921686 | Active Not Recruiting

• 1 other identifier: H-28604
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Eosinophilic Esophagitis; Gastroesophageal Reflux Disease

Keywords

Eosinophil; Reflux; Esophagus; Food allergy; Trouble Swallowing; Pediatrics; Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• pH monitoring

  24 hours

Other Outcomes (1)

• Immunoblotting

  At time of sample collection

Study Arms (3)

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

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

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

Interventions

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.

Control; Eosinophilic Esophagitis (EoE); Gastroesophageal Reflux Disease (GERD)

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

Related Links

• Physician Profile

Biospecimen

Retention: SAMPLES WITHOUT DNA

Three esophageal biopsy samples

MeSH Terms

Conditions

Eosinophilic Esophagitis; Gastroesophageal Reflux; Food Hypersensitivity; Deglutition Disorders

Interventions

Specimen Handling; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Esophagitis; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Esophageal Motility Disorders; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Data Collection; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Eric H Chiou, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 9, 2013
• First Posted: August 13, 2013
• Study Start: March 1, 2013
• Primary Completion: September 1, 2014
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 28, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)