Phenotypic Characterization and Biomarkers Investigation for Eosinophilic Esophagitis in Pediatric Patients

Study Overview
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Brief Summary
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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
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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: Symptoms score: General symptom score and/or Pediatric Eosinophilic Esophagitis Symptom Score (PEESS v2.0) - translated and adapted version for Brazilian Portuguese Endoscopic Score: Eosinophilic Esophagitis (EoE) Endoscopic Reference Score (EREFS) Peak eosinophil count (PEC) and histological features description Proteomic analyses Microbiome analyses Immunohistochemistry analyses

Official Title
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Phenotypic Characterization of Pediatric Patients With Esophageal Eosinophilia and Biomarkers Investigation for the Diagnosis of Eosinophilic Esophagitis

Conditions
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Eosinophilic Esophagitis, Gastroesophageal Reflux

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Eosinophilic Esophagitis - EoE<br>Diagnosis of pediatric EoE under current guidelines. | |
| Gastroesophageal reflux disease - GERD<br>Diagnosis of pediatric GERD under current guidelines. | |
| Control<br>Exclusion diagnosis of EoE or GERD, with non specific gastrointestinal general complaints. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biomarkers for the diagnose of Pediatric Eosinophil Esophagitis | Identify diagnostic biomarker, able to distinguish EoE patients from GERD patients and other nonspecific gastrointestinal complains | 2016 August - 2017 March and 2018 November-December | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endoscopic features of EoE | Evaluation of the EREFS 'ability (endoscopic reference score) to identify EoE patients and the inflammatory or fibrosis phenotype | 2017 January-March and 2018 November-December | 
| Symptoms of active EoE | Evaluation of the symptom score's ability to identify EoE patients in active disease | 2017 January-March and 2018 November-December | 
| Histological features of EoE | Evaluation of the histologic score's ability to identify EoE patients and the inflammatory or fibrosis phenotype | 2017 January-March and 2018 November-December | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Eosinophilic Esophagitis, Gastroesophageal Reflux, Diagnose, Biomarker