NCT06312059已完成2 期
Growth Tolerance and Safety Study of Healthy Term Infants Consuming a Goat or Cow Milk Based Infant Formula
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 409
- 试验地点
- 1
- 主要终点
- Growth as compared against WHO growth charts
研究概览
简要总结
This study is a non-inferiority, decentralized, randomized, double-blind, controlled clinical trial evaluating the growth, tolerance, and safety of a goat's-milk test infant formula (Test Formula 1; TF1) and a cow's-milk test infant formula (Test Formula 2; TF2), each compared to a cow's-milk infant formula commercially available in the United States (Control Formula; CF).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
RP Over stickered TP in blank packaging.
入排标准
- 年龄范围
- — 至 14 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy term infants (37 to 42 weeks gestation at birth) from a singleton birth as assessed by the investigator
- •Infants with a birth weight of >2500 g to <4500 g
- •Infants ≤11 days of age at enrollment; birth constitutes Day 0
- •Parent/legal guardian who has previously decided to exclusively feed infant formula and is willing to continue with formula feeding throughout the study
排除标准
- •A participant who meets any of the following criteria will be excluded from participation in the study:
- •Infant born with medical complications (e.g., neurological, cerebral palsy, etc.)
- •Infant with failure to thrive, fever, any GI tract abnormalities (e.g., short gut, gastroesophageal reflux, etc.), any congenital illness or malformation that may affect infant feeding or normal growth
- •Infant has been treated with prescription medications that in the Investigator's opinion could impact growth, gastrointestinal tolerance and/or development
- •Infant that has received oral or parenteral antibiotics prior to enrollment
- •Infant is taking and parent/legal guardian plans to continue (including over-the-counter medications, such as Mylicon® for gas), home remedies (such as juice for constipation), gastroesophageal reflux medications, herbal preparations, or rehydration fluids that, in the Investigator's opinion, might affect gastrointestinal tolerance. Use of the following are strongly discouraged for the duration of the trial:
- •Solid foods and juices
- •Vitamins and/mineral supplements, as the study product provided is nutritionally complete
- •Pre- and probiotics
- •Infant with family history (biological siblings or parents) of confirmed milk protein allergy (Parent's lactose intolerance is not disqualifying)
- •Parent(s)/Legal guardian(s) intent on feeding non-study formula, breastmilk, juices, or solid food during the study.
结局指标
主要结局
Growth as compared against WHO growth charts
时间窗: 16 weeks
Mean daily weight gain for infants fed TF1 and infants fed TF2, each compared to infants fed CF, from baseline through to Week 16
次要结局
- Safety(16 weeks)
研究者
研究点 (1)
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