Efficacy of JINLINGGUAN and TOFER Formula in Formula-fed Chinese Term Infants: A Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 180
- 试验地点
- 3
- 主要终点
- Average Change Rate of Stool Characteristic Index from Baseline to 6 and 12 weeks
研究概览
简要总结
Objective：The present trial aimed to assess efficacy and safety of Jin Ling Guan and Tofer infant formula on body growth, intestinal tolerance, gut microbiota and fecal residual nutrients as compared to breast-milk in term Chinese infants.
Participants：189 healthy termed-infants with ages of 5-14 days at the enrollment.
Study Design: A multiple-center, quasi-randomized,open labeled, controlled trial. Random allocation between the two infant formula.
Arms, Groups, and Intervention: (1) Breast milk-fed group: fed with human breast milk; (2) JINLINGGUAN Formula Group：fed with JINLINGGUAN infant formula (PRO-KIDO™ I-PROTECH®, Phase I); (3) TOFER Formula Group: feeding TOFER infant formula (TOFER®, Phase I). Random allocation performed between the two formula groups.
Intervention Duration: 12 weeks.
Visits: 1 week(baseline), 7 and 13 weeks of age
Outcome measures: (1) General information, general health and wellbeing, regular body check;(2) Anthropometric parameters: body length, body weight, and head circumferences; (3) Stool characteristics (color , volume, stool consistency, and frequency;(4)Behavior and habits; (5) Gut microbiota; (6) Residual nutrients in feces (nitrogen,total fat, fatty acids, minerals); (7) adverse events and concomitant medications; (8) compliance. Slopes of changes from baseline to 6 and 12 weeks post intervention in anthropometric parameters, stool characteristic index, fecal residual nutrients, pattern score of gut microbiota, behavior and habit index were be calculated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Researchers involved in laboratory tests will be blinded to the group status
入排标准
- 年龄范围
- 5 Days 至 14 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The mother had unequivocally decided not to breast-feed (for formula fed infants) or to breastfeed (for human milk fed infants)
- •Term infant of Chinese origin born at 37-42 gestation weeks
- •Birth weight: 2500-4000g
- •The infant is apparently healthy at birth and entry to study
- •Apgar after 5 minutes >7
- •age at the enrollment: 5-14 days
排除标准
- •Mother health condition: (psychological or physical) or socioeconomic problems that may interfere with the mother's ability to take care of her infant
- •The infant suffers from a major congenital abnormality or chromosomal disorder with a clinical significance that can be detected at birth
- •The infant suffers/ed from a disease requiring mechanical ventilation or medication treatment at the first week after birth (not including photo treatment for infantile hepatitis)
- •The infant suffers from any suspected or known metabolic or physical limitations interfering with feeding or normal metabolism
研究组 & 干预措施
Breast-Fed Group
The infants will be fed with human breast milk by their mother
干预措施: Breast milk (Other)
TOFER Formula Group
TOFER Infant formula,TOFER®: Infants will be fed by using TOFER® infant formula (Phase I baby formula) from baseline (about 5-14 days) to 13 weeks of age.
干预措施: TOFER Infant formula,TOFER® (Other)
JINLINGGUAN Formula Group
JINLINGGUAN Infant formula,PRO-KIDO™ I-PROTECH®: Infants will be fed by using JINLINGGUAN (PRO-KIDO™ I-PROTECH®) infant formula (Phase I baby formula) from baseline (about 5-14 days) to 13 weeks of age.
干预措施: JINLINGGUAN Infant formula,PRO-KIDO™ I-PROTECH® (Other)
结局指标
主要结局
Average Change Rate of Stool Characteristic Index from Baseline to 6 and 12 weeks
时间窗: 0, 6, 12 weeks
Slope of change at 0, 6 and 12 weeks in Stool Characteristic Index: calculated using stool color (using sample pictures), volume (small, normal or large using sample picture scale), stool consistency (runny, mushy, soft, formed or hard), and frequency
Average Change Rate of Fecal Residual Calcium from Baseline to 6 and 12 weeks
时间窗: 0, 6, 12 weeks
Slope of change at 0, 6 and 12 weeks in fecal residual calcium
Average Change Rate of Fecal Residual Nitrogen from Baseline to 6 and 12 weeks
时间窗: 0, 6, 12 weeks
Slope of change at 0, 6 and 12 weeks in Fecal Residual Nitrogen
Average Change Rate of Fecal Residual Fat from Baseline to 6 and 12 weeks
时间窗: 0, 6, 12 weeks
Slope of change at 0, 6 and 12 weeks in fecal residual total fat
次要结局
- Average Change Rate of Body Weight from Baseline to 6 and 12 weeks(0, 6, 12 weeks)
- Average Change Rate of body length from Baseline to 6 and 12 weeks(0, 6, 12 weeks)
- Average Change Rate of an Index of General health and wellbeing from Baseline to 6 and 12 weeks(0, 6, 12 weeks)
- Average Change Rate of Behavior and Habit Score from Baseline to 6 and 12 weeks(0, 6, 12 weeks)
- Average Change Rate of Head Circumference from Baseline to 6 and 12 weeks(0, 6, 12 weeks)
- Average Change Rate of Gut Microbiota Pattern Score from Baseline at 6 and 12 weeks(0, 6, 12 weeks)
- Average Change Rate of Pattern Score of Fecal Residual Fatty acids from Baseline at 6 and 12 weeks(0, 6, 12 weeks)
研究者
Yu-ming Chen
Professor
Sun Yat-sen University