NCT03090360
已完成
不适用
Growth of Infants Fed a New Term Infant Formula With a Prebiotic
Société des Produits Nestlé (SPN)7 个研究点 分布在 2 个国家目标入组 349 人开始时间: 2017年2月21日最近更新:
适应症Healthy
概览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Société des Produits Nestlé (SPN)
- 入组人数
- 349
- 试验地点
- 7
- 主要终点
- Growth
概览
简要总结
To evaluate the growth of healthy term infants fed an experimental infant formula with a prebiotic, a commercial control infant formula with a probiotic, but without a prebiotic and human breast milk
详细描述
Multisite, double-blind, randomized, controlled clinical trial. The purpose of the study is to determine if infants fed a standard infant formula with a prebiotic have a weight gain in line with infants fed a standard starter infant formula without a prebiotic.
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)
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
- •Written informed consent signed and dated
- •Infants whose parent(s)/Legally Authorized Representative (LAR) have reached the legal age of majority in Belgium
- •Infants whose parent(s)/LAR are willing and able to comply with scheduled visits, and the requirements of the study protocol.
- •Infants whose parent(s)/LAR are able to be contacted directly by telephone throughout the study.
- •Infants whose parent(s)/LAR have a working freezer.
- •Healthy term, singleton infant at birth.
- •At enrollment visit, post-natal age ≤ 14 days (date of birth = day 0).
- •At enrollment, birth weight ≥ 2500g and ≤ 4500g.
- •For formula-fed group, infant of parent(s)/LAR who have previously made the decision to formula feed their infant at the time of enrollment.
排除标准
- •Infants with conditions requiring infant feedings other than those specified in the protocol.
- •Infants receiving complementary foods or liquids.
- •Infants who have a medical condition or history that could increase the risk associated with study participation or interfere with the interpretation of study results.
- •Infants who are presently receiving or have received prior to enrollment medications that could interfere with the interpretation of study results.
- •Infants or infants whose parent(s)/LAR who in the Investigator's assessment cannot be expected to comply with the protocol or with study procedures.
结局指标
主要结局
Growth
时间窗: 120 days
Growth (weight gain velocity)
次要结局
- Fecal microbiota composition and diversity (16S rRNA sequencing and qPCR)(Every month up to 4 months of age)
- Fecal markers (pH, fecal organic acids, and protein markers of gut health)(Every month up to 4 months of age)
- Growth(Every month up to 6 months of age)
- Stool patterns (3-day GI symptom and behavior diary - stool frequency and stool consistency)(Every month up to 6 months of age)
- GI tolerance (3-day GI symptom and behavior diary - including GI symptoms, GI-related behaviors, and milk intake)(Every month up to 6 months of age)
- Gene expression (infant exfoliated and microbial cell gene expression by shotgun sequencing)(Up to 3 months of age)
- Adverse events / Morbidity(180 days)
研究者
研究点 (7)
Loading locations...
相似试验
已完成
不适用
Preterm Infant GrowthGrowthDevelopmentInfantNCT01162798Société des Produits Nestlé (SPN)150
已完成
不适用
Growth and Tolerance of Infants Fed Infant FormulasGrowth and ToleranceNCT01808105Abbott Nutrition424
已完成
不适用
Growth of Infants Fed New Starter FormulaDietary InterventionNCT01079208Société des Produits Nestlé (SPN)297
终止
不适用
Growth and Tolerance Trial on Infant Formula With HMOHealthy GrowthNCT04066413FrieslandCampina265
已完成
不适用
Study of Nutritional Suitability of a New Infant Formula for Term InfantsGrowthNCT02490852Ausnutria Hyproca B.V.304