NCT03884309已完成不适用
Tolerance, Compliance and Growth of Infants Fed an Extensively Hydrolyzed Infant Formula With Added Human Milk Oligosaccharides
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 12
- 主要终点
- Weight for Age
研究概览
简要总结
This is a single group, non-randomized, multicenter study to assess the effects of a hypoallergenic casein hydrolysate powdered infant formula on gastrointestinal (GI) tolerance, growth and compliance in an intended use infant population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- — 至 60 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant is presently consuming an extensively hydrolyzed infant formula (EHF) for persistent feeding intolerance symptoms, symptoms of suspected food protein (milk and/or soy) sensitivity, or other conditions where EHF is deemed an appropriate feeding.
- •Parent(s) of infants confirm their intention not to administer prescription medications, over the counter medications, home remedies, prebiotics, probiotics, herbal preparations or rehydration fluids that might affect GI tolerance.
- •Parent(s) confirm their intention to feed their infant the study product as the sole source of nutrition for the duration of the study.
- •Parent(s) confirm their intention not to administer vitamins, minerals (with the exception of Vitamin D supplements), solid foods or juices to their infant from enrollment through the duration of the study.
- •Participant's parent(s) or a legally authorized representative (LAR) has voluntarily signed and dated an informed consent form (ICF) approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB) and provided Health Insurance Portability and Accountability Act (HIPAA) (or other applicable privacy regulation) authorization prior to any participation in the study.
排除标准
- •An adverse maternal, fetal or participant medical history that is thought by the investigator to have potential for effects on growth, and/or development.
- •Participant is receiving oral or inhaled steroids.
- •Participant participates in another study that has not been approved as a concomitant study.
- •Participant has an allergy or intolerance to any ingredient in the study product.
- •Participant has been treated with antibiotics or other medications that in the opinion of the PI may affect growth, GI tolerance and/or development, within 2 weeks prior to enrollment.
结局指标
主要结局
Weight for Age
时间窗: Study Day 1 to Study Day 60
Change in weight for age z-score
次要结局
- Gastrointestinal Tolerance(Study Day 1 to Study Day 60)
- Head Circumference(Study Day 1 to Study Day 60)
- Length(Study Day 1 to Study Day 60)
研究者
研究点 (12)
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