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Morphological Markers of Gastroesophageal Reflux Disease (GERD)

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Searching Both is inclusive of interventional and observational studies.

Eligible Ages 8 Years - 18 Years
Gender All
More Inclusion & Exclusion Criteria

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).

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.


Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Baylor College of Medicine
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Eric H Chiou, MD
Principal Investigator Affiliation Baylor College of Medicine
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Overall Status Active, not recruiting
Countries United States

The disease, disorder, syndrome, illness, or injury that is being studied.

Eosinophilic Esophagitis, Gastroesophageal Reflux Disease
Study Website: View Trial Website
Additional Details

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

Arms & Interventions


: 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)

: 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.

: 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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Texas Children's Hospital, Houston, Texas



Texas Children's Hospital

Houston, Texas, 77030

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