NCT01109966终止不适用
A Prospective, Double Blind Randomised Controlled Trial to Evaluate the Immunological Benefits and Clinical Effects of an Elimination Diet Using an Amino Acid Based Formula (AAF)
Nutricia Research14 个研究点 分布在 3 个国家目标入组 34 人开始时间: 2010年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 34
- 试验地点
- 14
- 主要终点
- To evaluate the development of oral tolerance in infants with IgE mediated CMA on control or test AAF.
研究概览
简要总结
The purpose of this study is to evaluate whether a new version of an amino acid based formula improves tolerance to milk in cow's milk allergic infants/young children.
详细描述
Infants with CMA cannot tolerate proteins contained in milk, although they are able to tolerate amino acids which are the 'building blocks' of proteins. Unlike standard infant formulas which are made from milk proteins, amino acid formulas (AAF) are made from nonallergenic aminoacids plus all the other nutrients required to support growth and development.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 8 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants ≤ 8 months of age
- •Infants sensitised to cow's milk and diagnosed with IgE mediated cow's milk allergy confirmed by milk challenge or diagnosis of anaphylaxis to milk within the last 3 months
排除标准
- •Infants less than 2500 g at birth
- •Infants less than 37 weeks gestation
- •Infants with severe concurrent illness
- •Use of anti- histamines, systemic corticosteroids, systemic antibiotics or anti-mycotic drugs, and immuno-modulatory drugs
- •Infants consuming less than 500ml per day of their usual formula at study entry
- •Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements
- •Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study
结局指标
主要结局
To evaluate the development of oral tolerance in infants with IgE mediated CMA on control or test AAF.
时间窗: 2 years
次要结局
- To evaluate maturation of the GI immune system in IgE mediated CMA To confirm that the test formula is effective in the dietary management of CMA To assess frequency of other allergies(2 years)
研究者
研究点 (14)
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