Effects of Breast Milk Simulated Infant Formula: A 3-month Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 179
- 试验地点
- 1
- 主要终点
- Average Change Rate of Gut Microbiota Pattern Score from 1month to 3 month
研究概览
简要总结
Objective：The aim of this trial is to assess effects of Kieember and Yashili infant formula on body growth, behavior development, intestinal comfort, infectious diseases, allergic diseases, the absorption of nutrients and gut microbiota as compared to breast-milk in term infants aged 0-3 months.
Participants：144 healthy term infants aged less than 30 days at entry to study. Study Design: A open-label,parallel, controlled trial.
Arms, Groups, and Intervention: (1) Breast milk-fed group: fed with human breast milk; (2) Breast Milk Simulated Formula Group：fed with breast milk simulated infant formula (Ruibuen®Kieember, Phase I); (3) Traditional Formula Group: fed with traditional infant formula (Ruibuen®Yashili, Phase I).
Intervention Duration: 90 days.
Visits: 1month and 3month old.
Outcome measures: (1)Biochemical detection of feces (total fat, fatty acids, calcium, nitrogen);(2)Stool characteristics (frequency, color, volume, and stool consistency);(3)Anthropometric parameters (body length, body weight, and head circumferences);(4)Temperament and adaptive behavior;(5)Gut microbiota;(6)General health and wellbeing;(7)concomitant medications and adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 0 Days 至 30 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Term infant: Born at 37-42 gestation weeks
- •Birth weight: 2500-4000g (appropriate for gestational age)
- •The infant is in good health and Apgar after 5 minutes >7
- •The mother had unequivocally decided not to breastfeed (for formula fed infants) or to breastfeed (for human milk fed infants)
- •age at the enrollment: less than 30 days
排除标准
- •The mother is unable to take care of her infant on account of health condition (psychological or physical) or socioeconomic problems
- •The infant is born with a congenital malformation or chromosome abnormality with a clinical significance
- •The infant suffers from a disease requiring mechanical ventilation or medication in the first week of life (not including applying phototherapy of blue to cure neonatal jaundice)
- •The infant whose feeding or normal metabolism is affected by any suspected or unknown metabolic factors or physical limitations
- •The infant has been breastfed for more than 2 weeks (for formula fed infants)
- •Twins or multiple births
研究组 & 干预措施
Breast Milk-Fed Group
The infants will be breastfed during the study.
干预措施: Breast milk (Other)
Breast Milk Simulated Formula Group
Kieember Infant formula, Ruibuen®: Infants will be fed Kieember infant formula(Phase I) from baseline (1 month old) to 3 month old.
干预措施: Kieember Infant formula, Ruibuen® (Other)
Traditional Formula Group
Yashili Infant formula, Ruibuen®: Infants will be fed Yashili infant formula (Phase I) from baseline (1 month old) to 3 month old.
干预措施: Yashili Infant formula, Ruibuen® (Other)
结局指标
主要结局
Average Change Rate of Gut Microbiota Pattern Score from 1month to 3 month
时间窗: 1,3 months
Slope of change at 1 and 3 month in gut microbiota pattern score from 16S RNA sequencing.
Average Change Rate of body weight from 1month to 3 month
时间窗: 1,3 months
Slope of change at 1 and 3 month in body weigh.
Average Change Rate of body length from 1month to 3 month
时间窗: 1,3 months
Slope of change at 1 and 3 month in body length.
Average Change Rate of Fecal Residual Fatty Acid from 1month to 3 month
时间窗: 1,3 months
Slope of change at 1 and 3 month in Fecal Residual Fatty Acid.
Average Change Rate of Fecal Residual Nitrogen from 1month to 3 month
时间窗: 1,3 months
Slope of change at 1 and 3 month in Fecal Residual Nitrogen.
Average Change Rate of Fecal Residual Calcium from 1month to 3 month
时间窗: 1,3 months
Slope of change at 1 and 3 month in fecal residual calcium.
Average Change Rate of head circumferences from 1month to 3 month
时间窗: 1,3 months
Slope of change at 1 and 3 month in head circumferences.
次要结局
- Average Change Rate of Stool Characteristic Index from 1month to 3 month(1,3 months)
- Average Change Rate of Temperament Score from 1month to 3 month(1,3 months)
- Average Change Rate of an Index of General health and wellbeing from 1month to 3 month(1,3 months)
研究者
Huilian Zhu
Professor
Sun Yat-sen University