Eosinophilic Esophagitis: Towards Improved Management
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Active eosinophilic esophagitis (>15 eosinophils per high-power field)
研究概览
简要总结
The current project aims to improve the care for children and adolescents with eosinophilic esophagitis in a collaborative effort involving pediatric units at Oslo Unversity Hospital and Helse Bergen, Norway. Existing and new non-invasive biomarkers will be explored systematically, aiming to reduce the number of endoscopies and time on restricted diet.
详细描述
The overall aim of the current proposal is to improve the care for children and adolescents with EoE and reduce the need for complex elimination diets and repeated endoscopies.
Our objectives are to determine whether
-
at diagnosis the following are predictive for response to food elimination:
-
history of atopy, symptoms after food intake
-
eosinophil counts in biopsies and peripheral blood
-
total IgE, specific IgE, eosinophilic granula proteins, eosinophil progenitor cells in blood
-
key cytokines (Eotaxin-3, IL-5, IL-13)
-
eosinophil derived neurotoxin/EDN in oesophageal aspirates, blood samples and feces
-
circulating microRNAs
-
at follow-up biomarkers collected by non-invasive methods can predict endoscopic and histologic healing
-
eosinophil counts in esophageal brushes and peripheral blood
-
total IgE, specific IgE, eosinophilic granula protein, eosinophil progenitor cells
-
circulating cytokines like eotaxin-3, IL-5, IL-13
-
eosinophil derived neurotoxin/EDN in esophageal brushes, blood samples and feces
-
circulating microRNAs
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 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •a diagnosis of eosinophilic esophagitis
- •suspected but not yet confirmed eosinophilic esophagitis
排除标准
- •chronic severe conditions that preclude general anaestesia
- •lack of consent
结局指标
主要结局
Active eosinophilic esophagitis (>15 eosinophils per high-power field)
时间窗: 12 months
The eosinophil counts in a biopsy is used to classify active vs non-active eosinophilic esophagitis, and biomarkers are analysed using biopsy the gold standard to classify active vs inactive disease.
次要结局
未报告次要终点
研究者
Ketil Størdal
Dr
Oslo University Hospital