FARE Clinical Trial Finder
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
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|
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).
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.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Baylor College of Medicine|
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|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Overall Status||Active, not recruiting|
The disease, disorder, syndrome, illness, or injury that is being studied.
|Eosinophilic Esophagitis, Gastroesophageal Reflux Disease|
|Study Website:||View Trial Website|
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
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, 77030