Eosinophilic Esophagitis, Gastroesophageal Reflux
Conditions
Keywords
Eosinophilic Esophagitis, Gastroesophageal Reflux, Diagnose, Biomarker
Brief summary
The purpose of this study is to find out some potential biomarkers for the Eosinophilic Esophagitis (EoE) in pediatric patients through the prospective clinical characterization and assessment of samples collected during the diagnostic process
Detailed description
This study collects clinical information from pediatric patients between 0-18 years old who have been undergoing upper gastrointestinal endoscopy due to general complaints. The demographic, clinical symptoms, endoscopy, pH monitoring, and histology data are assessed during the diagnostic process. In the baseline endoscopy procedure samples (blood, saliva, esophageal tissue, and esophageal mucus) are taken. After diagnostic process of EoE and Gastroesophageal reflux disease (GERD) supported by International Guidelines the patients are divided into three groups - EoE, GERD, and Control. The techniques are used for patients characterization and assessment: 1. Symptoms score: General symptom score and/or Pediatric Eosinophilic Esophagitis Symptom Score (PEESS v2.0) - translated and adapted version for Brazilian Portuguese 2. Endoscopic Score: Eosinophilic Esophagitis (EoE) Endoscopic Reference Score (EREFS) 3. Peak eosinophil count (PEC) and histological features description 4. Proteomic analyses 5. Microbiome analyses 6. Immunohistochemistry analyses
Interventions
None listed
Sponsors
Federal University of Uberlandia
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
Inclusion criteria
* Pediatric patients who are undergoing upper gastrointestinal endoscopy for diagnostic purpose
Exclusion criteria
* Pediatric patients who are undergoing upper gastrointestinal endoscopy for therapeutic procedures * The presence of other eosinophilic diseases * Patients have been taken corticosteroids and/or gastric acid secretion inhibition drugs for the last four weeks
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Biomarkers for the diagnose of Pediatric Eosinophil Esophagitis | 2016 August - 2017 March and 2018 November-December | Identify diagnostic biomarker, able to distinguish EoE patients from GERD patients and other nonspecific gastrointestinal complains |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Endoscopic features of EoE | 2017 January-March and 2018 November-December | Evaluation of the EREFS 'ability (endoscopic reference score) to identify EoE patients and the inflammatory or fibrosis phenotype |
| Symptoms of active EoE | 2017 January-March and 2018 November-December | Evaluation of the symptom score's ability to identify EoE patients in active disease |
| Histological features of EoE | 2017 January-March and 2018 November-December | Evaluation of the histologic score's ability to identify EoE patients and the inflammatory or fibrosis phenotype |
Countries
Brazil
Outcome results
None listed