A Multicenter, Randomized, Controlled, Cross-over Study to Assess Hypoallergenicity of a New Amino-acid Based Infant Formula in Children With Cow's Milk Allergy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Hypoallergenicity as Assessed by Reaction to Amino-acid Based Infant Formula
研究概览
简要总结
This is a prospective, controlled, multi-country study to verifying the hypoallergenicity of the new amino acid-based formula in infants and children aged< 12 years with documented cow's milk protein allergy (CMPA).
详细描述
Not Provided
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- — 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with documented cow's milk allergy, confirmed by one of the following criteria, within six months prior to study start (visit 2):
- •Positive double-blind, placebo-controlled oral food challenge (DBPCFC) with cow's milk OR
- •Positive open or single-blind oral food challenge with cow's milk carried out under the supervision of a specialist in children with clear immediate reactions and a positive test for specific IgE (in serum [sIgE>0,35 KUI/L] or skin prick test [SPT ≥ 3 mm]) OR
- •Reported convincing allergic symptoms following an exposure to milk or a milk-containing food product and detectable serum milk-specific IgE or positive skin prick test
- •Aged ≤12 years of age at screening.
- •Expected consumption of a minimum of 250ml of study formula per day during the open challenge.
- •Written informed consent from one or both parents (depending on the local legislation) or legal representative.
排除标准
- •Children who receive breastfeeding at study enrolment.
- •Had any chronic medical diseases, chromosomal or major congenital anomalies, or major gastrointestinal disease/abnormalities (other the CMPA); had immunodeficiency; antihistamine [excluding eye drops] use in 7 days prior to a food challenge or oral steroid use within 14 days prior to enrolment; unstable asthma; severe uncontrolled eczema;
- •Severe anaphylactic reaction [required ≥ 2 doses of epinephrine] to milk or breast milk within the past 2 years;
- •Existing illness that could interfere with formula acceptance or identification of allergic reactions.
- •Investigator's uncertainty about the willingness or ability of the 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.
研究组 & 干预措施
Control formula
Commercially available Amino Acid Formula
干预措施: Commercially available Amino Acid Formula (Other)
New Amino Acid formula
New Amino-Acid based Infant Formula
干预措施: New Amino Acid formula (Other)
结局指标
主要结局
Hypoallergenicity as Assessed by Reaction to Amino-acid Based Infant Formula
时间窗: 14 days
To demonstrate that the test formula does not cause immediate and/or delayed allergic reactions to a double blind placebo control food challenge (DBPCFC) and/or a subsequent open food challenge (OFC). Incidence of immediate and/or delayed allergic reactions to the DBPCFC with the study product and/or active comparator and/or during the subsequent OPEN challenge phase of the study.
次要结局
- Cow's Milk Allergy Related Symptoms(14 days)