Phenotypic Characterization and Biomarkers Investigation for Eosinophilic Esophagitis in Pediatric Patients

Completed

• Conditions: Gastroesophageal Reflux; Eosinophilic Esophagitis

• Registration Number: NCT03069573
• Lead Sponsor: Federal University of Uberlandia

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

Study Timeline

• Study Start: 2015-01-01
• Primary Completion: 2016-08-31
• Study First Submitted: 2017-02-19
• Study First Submitted QC: 2017-02-27
• Study First Posted: 2017-03-03
• Study Completion: 2019-09-30
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-29
• Last Update Posted: 2020-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

Federal University of Uberlandia; 🇧🇷 Uberlândia, Minas Gerais, Brazil