NCT07711938尚未招募不适用
A Randomized, Double-Blind, Controlled Study to Compare Growth, Tolerability, and Safety of a Novel, Extensively Hydrolyzed Formula (eHF) Versus a Standard eHF in Full Term Infants With Cow's Milk Protein Allergy (CMPA)
Société des Produits Nestlé (SPN)0 个研究点目标入组 410 人开始时间: 2026年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 410
- 主要终点
- Weight Gain Over 16 Weeks
研究概览
简要总结
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
- 29 Days 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.
- •Parent(s)/LAR deemed able to provide written informed consent for participation of their infant in the study (in the opinion of the investigator).
- •Participant aged ≥29 days (>4 weeks) and <5 months (≤22 weeks) at time of enrollment.
- •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.
- •Congenital illness or malformation that may affect growth, or significant pre-natal and/or serious post-natal disease other than CMPA before randomization (per investigator's medical decision).
- •Demonstrated chronic malabsorption not due to CMPA.
- •History of severe anaphylaxis to CMP.
- •Infants whose parent(s)/LAR cannot be expected to comply with study procedures.
- •Currently participating or having participated in another clinical study since birth.
- •Infants with a history of confirmed food protein induced enterocolitis syndrome due to other foods than CMP or Heiner syndrome.
- •Infants with history of oral immunotherapy for CMPA.
- •Diagnosed eosinophilic esophagitis.
- •Received systemic oral or injected corticosteroids for more than 3 days (72 hours) within 2 weeks prior to the Screening Visit (topical corticosteroids allowed).
- •Received systemic antibiotics within 1 week prior to Screening Visit (topical antibiotics, e.g., mupirocin allowed).
- •Infants who are currently receiving treatment with immunomodulators (immunoglobulins, allergen extracts, or similar) or immuno-suppressants (azathioprine, cyclosporine or similar) within 2 weeks of Screening Visit (topical cyclosporine, tacrolimus, pimecrolimus or similar topical eczema treatments allowed), as well as infants with immune disorders which can compromise the immune function.
- •Infants with a 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 participant's ability to participate in the study (e.g., cardiovascular, pulmonary, gastrointestinal, hepatic, renal, neurological, musculoskeletal, endocrine or metabolic disorders, malignancy, major physical impairment, immunodeficiency, infectious disease or abnormal laboratory results as per the investigator's judgment).
- •Parent(s)/LAR being in any relationship or dependency with the sponsor, and/or the investigator, and/or study staff.
- •Underage parents (under 18 years old).
结局指标
主要结局
Weight Gain Over 16 Weeks
时间窗: 16 weeks
To demonstrate non-inferiority in growth in infants fed with the Test formula, compared to infants fed with the Control formula over the first 16 weeks of formula intake.
次要结局
- Incidence of Adverse Events of Special Interest (AESIs)(52 weeks)
- Growth Parameters: Weight(52 weeks)
- Growth Parameters: Length(52 weeks)
- Quality of Life Scores (ITQOL)(52 weeks)
- Stool Frequency and Stool Characteristics (BITSS)(52 weeks)
- Resolution of CMPA-Related Symptoms(52 weeks)
- Formula intake compliance(52 weeks)
- Healthcare resources utilization(52 weeks)
- Growth Parameters: Head Circumference(52 weeks)
- Quality of Life Scores (FLIP)(52 weeks)
- Resolution of Cow Milk Protein Allergy (CMPA)-Related Symptoms(52 weeks)
研究者
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