跳至主要内容
临床试验/NCT05622214
NCT05622214招募中不适用

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)

Rambam Health Care Campus1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年7月25日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ron Shaoul MD

Director, Pediatric Gastroenterology institute

Rambam Health Care Campus

研究点 (1)

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