Growth, Gut Health, Immune Function, and Sleep Status in Infants and Young Children Fed With Novel Infant Formula : A Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change in Height
研究概览
简要总结
Randomized, controlled study consisting of three parallel arms to investigate the effects of novel infant formula on growth, gut health, immune function, and sleep status in healthy infants and young children aged 12-18 months.
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
- None
入排标准
- 年龄范围
- 12 Months 至 18 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy full-term infants (gestational age 37-42 weeks).
- •Age 12-18 months (inclusive).
- •Weight below the 75th percentile according to the "Growth Reference Standards for Chinese Children Under 7 Years Old".
- •Has started or plans to start stage 3 formula feeding before enrollment.
- •Guardian voluntarily signs written informed consent and is able to comply with all study procedures including regular visits, intervention plan, and laboratory tests.
排除标准
- •Known allergy to milk protein or the study formula.
- •Known allergic constitution or high allergy risk (parent with allergic constitution).
- •Malnutrition assessed by investigator.
- •Chronic infectious disease, metabolic disease, genetic disease, or any other condition affecting feeding or growth and development.
- •History of preterm birth or admission to Neonatal Intensive Care Unit (NICU), excluding phototherapy for jaundice.
- •Severe constipation or diagnosis of other functional gastrointestinal disorders.
- •Cognitive or developmental disorders.
- •Any other condition that, in the investigator's judgment, makes the infant unsuitable for participation.
研究组 & 干预措施
Investigational Formula 1
干预措施: Investigational Formula 1 (Dietary Supplement)
Investigational Formula 2
干预措施: Investigational Formula 2 (Dietary Supplement)
Control: Commercial Infant Formula or Dairy Products
结局指标
主要结局
Change in Height
时间窗: Baseline (Day -7) to Day 90
Measured in centimeters (cm)
Change in Weight
时间窗: Baseline (Day -7) to Day 90
Measured in kilograms (kg)
Comprehensive Nutritional Development Assessment
时间窗: Baseline (Day -7) to Day 90
(1) Annual growth rate (cm/year); (2) MUAC to head circumference ratio; (3) Weight-for-age Z-score (WAZ); (4) Length-for-age Z-score (LAZ); (5) Weight-for-length Z-score (WLZ); (6) BMI-for-age Z-score (BAZ).
次要结局
- Change in Salivary sIgA(Baseline (Day -7) to Day 90)
- Change in Salivary Lysozyme(Baseline (Day -7) to Day 90)
- Change in Fecal sIgA(Baseline (Day -7) to Day 90)
- Change in Fecal Calprotectin(Baseline (Day -7) to Day 90)
- Change in Fecal Alpha-1 Antitrypsin (AAT)(Baseline (Day -7) to Day 90)
- Change in Gut Microbiome Composition (Metagenomics)(Baseline (Day -7) to Day 90)
- Change in Fecal Metabolome (Non-targeted Metabolomics)(Baseline (Day -7) to Day 90)
- Change in IGSQ Score(Baseline (Day -7) to Day 90)
- Change in Stool Consistency (Brussels Infant Stool Hardness Scale)(Baseline (Day -7) to Day 90)
- Change in TSAS Score(Baseline (Day -7) to Day 90)