NCT01809951已完成不适用
A Prospective, Open-label, Post-marketing Observational Study to Document the Use of Soy-based Infant Formula With Low Chain Polyunsaturates (LCP) in Infants With Symptoms Suggestive to Cow's Milk Allergy
Melva Louisa1 个研究点 分布在 1 个国家目标入组 534 人开始时间: 2011年8月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 534
- 试验地点
- 1
- 主要终点
- Parent's acceptance in the feeding of a soy-based infant formula with LCP in infants with symptoms suggestive adverse reactions to cow milk protein
研究概览
简要总结
The use of soy-isolate protein based formula for infants with cow's milk protein intolerance is common in Indonesia, however, there has not been any systematic collection of clinical data to determine the formula's gastrointestinal tolerance, and the parent's perceptions regarding the formula.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Months 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •infants of 6 - 12 months of age
- •full term infants
- •birth weight more than 2500 grams
- •infants developed symptoms suggestive adverse reactions to cow's milk protein in the investigator's clinical judgements
- •subject is prescribed a soy-based infant formula by physician
排除标准
- •established/suspected hypersensitivity fo soy
- •presence of adverse reactions to cow's milk caused by coincidental infections or other systemic disease
- •history of blood group incompatibility, premature delivery, HIV infections, major congenital abnormalities, systemic diseases
- •presence of severe gastrointestinal disorder
- •subject is participating in any interventional clinical study
结局指标
主要结局
Parent's acceptance in the feeding of a soy-based infant formula with LCP in infants with symptoms suggestive adverse reactions to cow milk protein
时间窗: 4-week
次要结局
- percentage of infants with gastrointestinal adverse events(4-week)
- percentage of infants with adverse events(4-week)
研究者
Melva Louisa
PhD
Indonesia University
研究点 (1)
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