NCT03881722已完成3 期
Effect of Magnesium Alginate in Infants With Gastroesophageal Reflux.
Policlinico Hospital2 个研究点 分布在 1 个国家目标入组 89 人开始时间: 2016年6月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 89
- 试验地点
- 2
- 主要终点
- Infant Gastro-Esophageal Reflux Questionnaire Revised
研究概览
简要总结
Recurrent regurgitation stress the infants and their parents and often results in an inappropirate use of PPI prescription in infancy. The aim of this study is to evaluate the efficacy of Mg alginate in infants with symptoms of gastroesophageal reflux.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Weeks 至 1 Year（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •symptoms suggestive of GER, evaluated through a validated questionnaire (Infant Gastroesophageal Reflux Questionnaire Revised: I-GERQ-R > 16)
- •informed consent signed
排除标准
- •congenital or chronic diseases
- •use of anti acid drugs
结局指标
主要结局
Infant Gastro-Esophageal Reflux Questionnaire Revised
时间窗: through study completion, an average of 1 month
12-item validated questionnaire called Infant Gastro-Esophageal Reflux Questionnaire Revised (I-GERQ-R) which include different questions about regurgitation, crying, feeding and respiratory problems
次要结局
未报告次要终点
研究者
Prof. Maria Elisabetta Baldassarre
Researcher
Policlinico Hospital
研究点 (2)
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