NCT01569776已完成不适用
Evaluation of Hypoallergenicity of an Amino Acid-Based Infant Formula
Société des Produits Nestlé (SPN)17 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2012年4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
- 入组人数
- 37
- 试验地点
- 17
- 主要终点
- occurrence of allergic reactions
研究概览
简要总结
The primary objective of this clinical trial is to determine whether a new amino acid-based formula is hypoallergenic as defined by the American Academy of Pediatrics (2000), demonstrating that the test formula does not provoke allergenic activity in 90% of infants or children with confirmed cow's milk allergy (CMA) with 95% confidence as compared to a commercially available hypoallergenic formula.
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)
- •2 months to ≤12 years of age at enrollment
- •Documented CMA within 6 months prior to enrollment
- •Otherwise healthy
- •Asthma, atopic dermatitis and/or rhinitis must be well-controlled, if applicable
- •Expected daily intake of at least 8 oz (240ml) 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 okay)
- •Immunodeficiency
- •Anti-histamine use in 7 days prior to the first food challenge (eyedrops are permitted)
- •Oral steroid use within 14 days prior to enrollment (intranasal and topical corticosteroid use are permitted)
- •Unstable asthma
- •Severe uncontrolled eczema
- •Severe anaphylactic reaction to milk within the last 2 years
- •Severe anaphylactic reaction to breastmilk within the last 2 years
- •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
occurrence of allergic reactions
时间窗: 14 days
occurrence of allergic reactions to double-blind placebo controlled food challenge (DBPCFC)
次要结局
- Digestive Tolerance(one week)
研究者
研究点 (17)
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