Phenotypic Characterization and Biomarkers Investigation for Eosinophilic Esophagitis in Pediatric Patients

Federal University of Uberlandia

Status: Completed

Conditions: Eosinophilic Esophagitis; Gastroesophageal Reflux

Study type: Observational

Funder types: Other

Identifiers

NCT03069573

CAAE-36787714.0.0000.5152

Details and patient eligibility

About

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

Full 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

Enrollment: 110 patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

110 participants in 3 patient groups

Eosinophilic Esophagitis - EoE

Description:

Diagnosis of pediatric EoE under current guidelines.

Gastroesophageal reflux disease - GERD

Description:

Diagnosis of pediatric GERD under current guidelines.

Control

Description:

Exclusion diagnosis of EoE or GERD, with non specific gastrointestinal general complaints.