An Open Label, Pilot Study Assessing the Efficacy and Tolerability of 12-weeks Treatment With Almond and Buckwheat Based Formula in Pediatric Patients With Active Eosinophilic Esophagitis (EoE)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Improvement in Pediatric Eosinophilic Esophagitis Symptom Severity Module (PEESS), endoscopic and histological scoring
研究概览
简要总结
Eosinophilic esophagitis (EoE) is a chronic, relapsing, immune-mediated esophageal disease. Clinical manifestations in infants and toddlers generally include vomiting, food refusal, choking with meals and, less commonly, failure to thrive. The management of the disease includes dietary and pharmaceutical interventions, and the goal of the treatment should ideally be both the resolution of symptoms and the normalization of the macroscopic and microscopic abnormalities. Milk is the most common food trigger identified, followed by wheat, soy, and eggs. The aim of the study is to examine the tolerability of a new plant based formula made of minimally processed almond and buckwheat and enriched with vitamins and minerals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 18 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients with active EoE (naïve and experienced)
- •Ages 1-18 years
排除标准
- •Change in dosing of Proton pump inhibitors (PPI) medication
- •Local steroid treatment < 1 month
- •Refusal to comply with study protocol
- •Known allergy to almonds and buckwheat
- •Use of dairy during the study
结局指标
主要结局
Improvement in Pediatric Eosinophilic Esophagitis Symptom Severity Module (PEESS), endoscopic and histological scoring
时间窗: 12 weeks
Improvement in PEESS, endoscopic and histological scoring (assessed at week 0 and week 12)
次要结局
未报告次要终点
研究者
Ron Shaoul MD
Director, Pediatric Gastroenterology institute
Rambam Health Care Campus
