NCT06830681终止不适用
A Growth, Tolerability, and Safety Study of a Novel Extensively Hydrolyzed Formula (eHF) in Infants With Cow's Milk Protein Allergy (CMPA)
Société des Produits Nestlé (SPN)1 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2025年1月7日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Growth
研究概览
简要总结
CMPA-GO Study: Growth and safety Outcomes in infants with CMPA fed a novel extensively hydrolyzed formula
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 4 Weeks 至 22 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Full term infant (gestational age ≥37 weeks and ≤42 weeks).
- •Birth weight ≥2500 g and ≤4500 g.
- •Infant aged ≥29 days (>4 weeks) and <5 months (≤22 weeks).
- •Not breastfed at time of Screening Visit.
- •History of an immediate-type (IgE-mediated) allergic reaction to a cow's milk-containing food or at least 2 persistent severe symptoms suggestive of delayed-onset (non-IgE-mediated) CMPA.
排除标准
- •Prior use of eHF, HRF or AAF for more than 2 weeks before randomization.
- •Demonstrated chronic malabsorption not due to CMPA.
- •History of anaphylaxis to CMP.
- •Participants with a history of confirmed Food Protein-induced Enterocolitis Syndrome (FPIES) or Heiner syndrome.
- •Any contraindication to the open OFC (eg. unstable respiratory disease), or any disorder in which epinephrine is contraindicated.
- •History of any immunotherapy for CMPA.
- •Past or current disease or disorder which, in the opinion of the Investigator or the sponsor either places the participant at risk because of participating in the study or may influence the results of the study, or the subject's ability to participate in the study.
结局指标
主要结局
Growth
时间窗: 16 weeks
To assess the growth by body weight (in g), body length (in cm) and head circumference (in cm) of infants fed with the Test formula, compared to infants fed with the Control formula over 16 weeks of formula use.
次要结局
- Safety via reporting of adverse events (AEs) and serious adverse events (SAEs)(52 weeks)
- Tolerability(52 weeks)
- Growth(52 weeks)
- Stool frequency and characteristics(52 weeks)
- Quality of life(52 weeks)
研究者
研究点 (1)
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