NCT04416217已完成不适用
Adrenal Suppression in Pediatric Eosinophilic Esophagitis Treated With Topical Steroids - A Multicenter, Prospective, Observational Safety Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 4
- 主要终点
- Growth failure
研究概览
简要总结
This observational study will follow pediatric patients with eosinophilic esophagitis who are scheduled to begin topical steroid treatment, from the initiation of treatment longitudinally to determine the safety profile of the drug.
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
- •Age <18 years at the time of enrollment.
- •Males and Females are included.
- •Patients diagnosed with EoE as defined by age appropriate signs of esophageal dysfunction (in older children and adolescents - dysphagia, impacted food bolus, foreign body impaction, vomiting, and GERD not responsive to high dose proton pump inhibitors. In infants and young children - failure to thrive, poor feeding, vomiting, food bolus impaction)
- •Histopathological finding of ≥15 eosinophils/high power field (X400) on at least one esophageal biopsy.
- •After discussing the available treatment options with the gastroenterologist, the patient has chosen oral topical steroid treatment (either as a first treatment or after failure of other dietary or medical treatment).
排除标准
- •Known alternative causes of esophageal eosinophilia.
- •Legal guardian unable or unwilling to sign informed consent..
- •Known allergy to topical steroids ingredients
- •Patient will not be available for follow-up for at least the 3 month assessment and ACTH test.
- •Known pregnancy
- •Use of oral systemic steroids in the 6 months prior to inclusion in the study. Use of systemic steroids once in the study will not lead to study termination, but such use will need to be reported in the medication changes and use page of the following visit.
结局指标
主要结局
Growth failure
时间窗: 36 months
Rates of decreased Height for age after 12 months of treatment.
Adrenal suppression
时间窗: 12 months
Rates of pathological adrenocorticotropic hormone (ACTH) tests at 3 and 12 months of topical steroid use
次要结局
- Bone mineral density(3 years)
- Histological remission 3 months(3 months)
- Hyperglycemia(12 months)
- Clinical remission(12 months)
- Elevated Liver Enzymes(3 months)
- Histological remission 12 months(12 months)
研究者
Noam Zevit
Attending Pediatric Gastroenterologist
Schneider Children's Medical Center, Israel
研究点 (4)
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