NCT01278446已完成不适用
Evaluation of Hypoallergenicity of a 100% Whey, Extensively Hydrolyzed Infant Formula
Société des Produits Nestlé (SPN)18 个研究点 分布在 1 个国家开始时间: 2011年2月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 试验地点
- 18
- 主要终点
- Hypoallergenicity
研究概览
简要总结
The primary objective of this clinical trial is to determine whether a new extensively hydrolyzed infant formula is hypoallergenic.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Months 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Born at term (>36 weeks gestation)
- •Two (2) months to ≤ 12 years of age at enrollment
- •Documented Cow's Milk Allergy (CMA) within the 6 months prior to enrollment by:
- •Reported convincing allergic symptoms following an exposure to milk or a milk-containing food product and [detectable serum milk-specific IgE (>0.7 kIU/L) or positive skin prick test (wheal greater than 5 mm]), OR
- •Physician-supervised oral food challenge that elicited immediate allergic symptoms, OR
- •Results of laboratory tests highly predictive of clinical reactivity to milk
- •Serum milk IgE ≥15 [kIU/L]or ≥ 5 [kIU/L if younger than 1 year OR,
- •Skin prick tests mean wheal >10 mm
- •Otherwise healthy
- •If subject has asthma, atopic dermatitis, and/or rhinitis, must be well controlled
- •Expected daily intake of at least 8 oz (240 ml) of the study formula during the open challenge phase
- •Having obtained his/her legal representative's informed consent.
排除标准
- •Children consuming mother's milk at the time of inclusion and during the trial
- •Any chromosomal or major congenital anomalies
- •Any major gastrointestinal disease or abnormalities other than CMA
- •Chronic medical diseases (ie seizure disorders, chronic lung disease, heart problems (heart murmurs acceptable)
- •Immunodeficiency
- •Receiving free amino acid formula
- •Anti-histamine use in 7 days prior to the first food challenge (eyedrops are acceptable)
- •Oral steroid use within 14 days prior to enrollment (intranasal and topical corticosteroids are okay)
- •Unstable asthma
- •Severe uncontrolled eczema
- •Recent ( within the last 3 months) severe anaphylactic reaction to milk
- •Subject who in the Investigator's assessment cannot be expected to adhere to the study protocol
- •Currently participating in another clinical trial
结局指标
主要结局
Hypoallergenicity
时间窗: 14 Days
To demonstrate that the test formula does not provoke allergenic activity
次要结局
- Digestive Tolerance(1 Week)
研究者
研究点 (18)
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