Phenotypic Characterization of Pediatric Patients With Esophageal Eosinophilia and Biomarkers Investigation for the Diagnosis of Eosinophilic Esophagitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Biomarkers for the diagnose of Pediatric Eosinophil Esophagitis
研究概览
简要总结
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
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients who are undergoing upper gastrointestinal endoscopy for diagnostic purpose
排除标准
- •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
结局指标
主要结局
Biomarkers for the diagnose of Pediatric Eosinophil Esophagitis
时间窗: 2016 August - 2017 March and 2018 November-December
Identify diagnostic biomarker, able to distinguish EoE patients from GERD patients and other nonspecific gastrointestinal complains
次要结局
- Histological features of EoE(2017 January-March and 2018 November-December)
- Endoscopic features of EoE(2017 January-March and 2018 November-December)
- Symptoms of active EoE(2017 January-March and 2018 November-December)
研究者
Cristina Palmer Barros
Professor
Federal University of Uberlandia