Growth of Infants Fed a New Term Infant Formula With a Prebiotic
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 349
- 试验地点
- 8
- 主要终点
- Growth
研究概览
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.
研究组 & 干预措施
Placebo comparator (Control)
Starter infant formula with a probiotic and without a prebiotic. Volumes of feed depend on age, weight and appetite.
干预措施: Infant formula (CF) (Dietary Supplement)
Experimental Formula (Test)
Starter infant formula with a probiotic and prebiotic. Volumes of feed depend on age, weight and appetite.
干预措施: Infant Formula (EF) (Dietary Supplement)
Breastfed reference group
Breastfed reference group
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)