Overview

This trial is active, not recruiting.

Conditions eosinophilic esophagitis, gastroesophageal reflux disease
Treatment sample collection and questionnaire
Sponsor Baylor College of Medicine
Start date March 2013
End date September 2014
Trial size 54 participants
Trial identifier NCT01921686, H-28604

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Arm
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
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.
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
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.
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
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.

Primary Outcomes

Measure
TEM analysis
time frame: at time of sample collection

Secondary Outcomes

Measure
pH monitoring
time frame: 24 hours

Eligibility Criteria

Male or female participants from 8 years up to 18 years old.

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).

Additional Information

Official title Dilation of Intercellular Spaces as Morphological Markers of Gastroesophageal Reflux Disease (GERD)In Children
Principal investigator Eric H Chiou, MD
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
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Baylor College of Medicine.