Effect of Magnesium Alginate on Gastroesophageal Reflux in Infants.
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- Evaluation of symptom scores
研究概览
简要总结
A randomized controlled cross-over trial in full-term infants affected by symptoms suggestive of GER, evaluated through a validated questionnaire (Infant Gastroesophageal Reflux Questionnaire Revised).
The parents of all of the enrolled infants will be reassured on the benign nature of the condition and will advise to apply lifestyle changes for one week.
Than, the patients will be randomized into one of the two sequence treatment groups. (group A: Mg alginate/thickened formula; group B: thickened formula/Mg alginate) for two weeks. Evaluation of symptom scores will be performed at day 0, day 7, day 21 and day 35.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 3 Months 至 1 Year（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •full-term ages 3 to 12 months, affected by symptoms suggestive of GER.
- •infant regurgitation defined according to the Rome IV criteria
- •informed consent
排除标准
- •Evidence of chronic diseases, hepatic, renal, or cardiac diseases, metabolic or central nervous system diseases, or use of acid suppressor treatment (H2-receptor antagonists or proton pump inhibitors [PPIs]), thickened formula, or a history of prematurity or atopy
研究组 & 干预措施
Group A
Group A: Mg alginate/thickened formula
干预措施: thickened formula (Dietary Supplement)
Group A
Group A: Mg alginate/thickened formula
干预措施: Mg alginate (Dietary Supplement)
Group A
Group A: Mg alginate/thickened formula
干预措施: reassurance with lifestyle changes (Behavioral)
Group B
Group B: thickened formula/Mg alginate
干预措施: reassurance with lifestyle changes (Behavioral)
Group B
Group B: thickened formula/Mg alginate
干预措施: thickened formula (Dietary Supplement)
Group B
Group B: thickened formula/Mg alginate
干预措施: Mg alginate (Dietary Supplement)
结局指标
主要结局
Evaluation of symptom scores
时间窗: From day 0 to day 35
Infant Gastroesophageal Reflux Questionnaire Revised
次要结局
未报告次要终点
研究者
Prof. Maria Elisabetta Baldassarre
MD
Policlinico Hospital