NCT03858426Unknown不适用
Prospective Multicenter Nationwide Registry of Children With Eosinophilic Esophagitis
Sociedad Espanola de Gastroenterologia, Hepatologia y Nutricion Pediatrica1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2019年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Complete histological remission
研究概览
简要总结
- Registry of demographic, clinical, endoscopic and histological data at baseline.
- Registry of patients treated with PPI:
- Clinical, endoscopic and histological response at 8-12 weeks of induction treatment
- Clinical, endoscopic and histological response at 6 and 12 months weeks of maintenance treatment
- Registry of patients treated with two foods elimination diet:
- Clinical, endoscopic and histological response at 8-12 weeks of induction treatment
- Identification of food trigger: milk, gluten or milk and gluten
- Clinical, endoscopic and histological response at one year elimination of food trigger
- Registry of adverse events
- Registry of patients treated with swallowed steroids (budesonide or fluticasone):
- Clinical, endoscopic and histological response at 8-12 weeks of induction treatment
- Clinical, endoscopic and histological response at 6 months of maintenance steroid treatment
- Registry of adverse events
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
- 1 Month 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children from 1 month to 18 years with a new diagnosis of eosinophilic esophagitis (EoE) according to the recent European guidelines (symptoms of esophageal dysfunction + eosinophilic infiltrate of the esophagus > 15 eos / CGA)
- •And that they need to start treatment with any of the following options: PPI, diet excluding cow's milk and gluten, or swallowed corticosteroids .
排除标准
- •Presence of pathological eosinophilia at the gastric or duodenal level (eosinophilic gastroenteritis)
- •Simultaneous treatment with more than one treatment modality (PPI, empirical elimination diet, swallowed corticosteroids).
结局指标
主要结局
Complete histological remission
时间窗: 12 weeks
Complete histological remission response defined as ≤5 eosinophils/hpf in all biopsies performed
次要结局
- Partial histological remission(12 weeks)
- Clinical remission(12 weeks)
研究者
Carolina Gutierrez Junquera
Principal Investigator
Sociedad Espanola de Gastroenterologia, Hepatologia y Nutricion Pediatrica
研究点 (1)
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