Morphological Markers of Gastroesophageal Reflux Disease (GERD)
Key facts
- Who runs it
- Baylor College of Medicine
- Where
- Houston, United StatesSee the site
- Trial code
- Status
- Suspended
- People taking part
- 54 people enrolled
- Started
- Mar 2013
- Expected to end
- Dec 2026
- Type of study
- Observational, 3 groups
- Treatments tested
- Sample collection and Questionnaire
- Record updated
- 17 August 2026
- Why it stopped
- Study objectives were not met and lack of funding
Who can take part
- Age
- 8 years to 18 years
- Sex
- Women and men
- Healthy volunteers
- Can take part
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- 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
Who cannot take part
- Previous esophageal or gastric surgery
- History of Barrett's esophagus
- History of congenital defect/malformation of the esophagus
- Diagnosis of Crohn disease
- Symptoms of GERD or EoE (including heartburn, regurgitation, difficulty swallowing, painful swallowing)
Where in United States
- Texas Children's HospitalHouston, United States
About the trial
What the trial wants to find out
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.
The 3 groups in the trial
- 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)
Treatment: 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.
Treatment: 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).
Treatment: Sample collection and Questionnaire
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Dilation of Intercellular Spaces as Morphological Markers of Gastroesophageal Reflux Disease (GERD)In Children
- Record updated
- 17 August 2026