NCT05731206暂停不适用
Study to Assess Hypoallergenicity of a Hydrolysed Protein Formula in Children With Confirmed Cow's Milk Allergy
Nutricia Research1 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2024年7月31日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Hypoallergenicity
研究概览
简要总结
Study to demonstrate hypoallergenicity of a hydrolysed protein infant formula in a population of children with confirmed cow's milk allergy.
详细描述
The study consists of a double-blind, placebo-controlled food challenge, followed by a single arm open challenge.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
double-blind
入排标准
- 年龄范围
- 0 Days 至 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants and children aged up to 3 years.
- •Diagnosed with cow's milk allergy (or re-confirmed), within two months prior to the study (challenge day #1), by:
- •Physician-supervised double-blind oral food challenge; or
- •Physician-supervised open oral food challenge that elicited objective immediate allergic reactions; or
- •Report of convincing allergic reaction to cow's milk or a milk-containing food product, in conjunction with presence of milk-specific serum Immunoglobuline E (IgE) level > 0.7 kilounit per liter (U/L) or by skin prick test (wheal size ≥ 3mm).
- •Willing to switch to a different hypoallergenic formula
- •On elimination diet (commercially available, hypoallergenic infant formula ) and free of clinical symptoms, or with controlled stable symptoms, for at least one week preceding the study (challenge day #1).
- •Expected minimal consumption of 144ml of test product/day during the open challenge.
- •Written informed consent provided by parents/guardians, according to local law.
排除标准
- •Infants/children who are more suitable to use AAF as first-line formula, including but not limited to those with high risk of anaphylaxis (prior history of anaphylaxis and currently not using eHF) or severe forms of non-IgE-mediated CMA such as eosinophilic oesophagitis, enteropathies, or Food Protein-Induced Enterocolitis Syndrome (FPIES).
- •Diagnosis or known allergy to any of the ingredients in the test product.
- •Congenital anomalies which will interfere with oral feeding or gastrointestinal tract, other chronic diseases (including but not limited to cardiovascular disease, malignancy, hepatic disease, renal disease, haematological disease, neurological disease, immunological and endocrine disease), major gastrointestinal disease/abnormalities, or any other medical condition that could interfere with the identification of allergic reactions.
- •(Twin / triplet) sibling of an infant/child already participating in the study.
- •Investigator's uncertainty about the willingness or ability of the subject and his/her parents 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.
- •Employees and/or children/family members or relatives of employees of Nutricia Research or the participating study sites.
结局指标
主要结局
Hypoallergenicity
时间窗: 25-35 days
The percentage of children tolerating the formula tested by double-blind, placebo-controlled food challenge and a subsequent open challenge.
次要结局
未报告次要终点
研究者
研究点 (1)
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