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NCT Number: NCT03069573

Phenotypic Characterization and Biomarkers Investigation for Eosinophilic Esophagitis in Pediatric Patients

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

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Key information

Conditions

Eosinophilic Esophagitis Deglutition Disorders Digestive System Diseases Disease Eosinophilia Esophageal Diseases Esophageal Motility Disorders Esophagitis Gastroenteritis Gastroesophageal Reflux Gastrointestinal Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Leukocyte Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Federal University of Uberlandia

Uberlândia, Minas Gerais, 38400-902, Brazil

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Biomarkers for the diagnose of Pediatric Eosinophil Esophagitis

    Time frame: 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 outcomes

  1. Endoscopic features of EoE

    Time frame: 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

  2. Symptoms of active EoE

    Time frame: 2017 January-March and 2018 November-December

    Evaluation of the symptom score's ability to identify EoE patients in active disease

  3. Histological features of EoE

    Time frame: 2017 January-March and 2018 November-December

    Evaluation of the histologic score's ability to identify EoE patients and the inflammatory or fibrosis phenotype

Sponsors and collaborators

Lead sponsor

Federal University of Uberlandia

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2019
First posted
Mar 3, 2017
Registry last updated
Oct 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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