A Randomized, Controlled, Double-blind Parallel Group Trial to Study the Effects of an Infant Formula and a follow-on Formula Containing Bio-active Ingredients on Growth, Tolerance and Infections in Healthy Term Infants
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 456
- 试验地点
- 3
- 主要终点
- infection-related morbidity episodes, parent-reported
研究概览
简要总结
In this clinical trial, the growth (weight for age), product tolerance (product intake, comfort) and infection-related symptoms of healthy infants consuming an IF and FOF containing bio-active ingredients will be evaluated and compared to a group of infants consuming a standard IF and FOF.
详细描述
In this clinical trial, the growth (weight for age), product tolerance (product intake, comfort) and infection-related symptoms of healthy infants consuming an IF and FOF containing bio-active ingredients will be evaluated and compared to a group of infants consuming a standard IF and FOF, until the age of 1y. 456 healthy term infants who are exclusively formula-fed will be included <2mo of age. An exploratory follow-up assessment will be done at the age of 2 and 3 years to study sustained health effects.
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
- 5 Days 至 60 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Full-term infants
- •Healthy birthweight: 2500 g ≤ birthweight ≤ 4200 g
- •Boys and girls
- •Apparently healthy at birth and screening
- •Weight-for-age Z-score (WAZ) at screening within the normal range according to WHO Child Growth Standards
- •Age at enrolment: ≤60 days of age
- •If age at inclusion ≤1 month: infants exclusively formula fed for at least 5 days prior to inclusion
- •If 1 month < age at inclusion ≤ 2 months: infants exclusively formula fed since 1 month old2
- •Being available for follow up until the age of 12 months
- •Written informed consent from parent(s) and/or legal guardian(s) aged ≥18 years
排除标准
- •Severe acquired or congenital diseases, mental or physical disorders, including cow's milk protein allergy (CMA), lactose intolerance and diagnosed medical conditions that are known to affect study outcomes (e.g. functional gastro-intestinal disorders (FGID))
- •Incapability of parents to comply with the study protocol
- •Illiterate parents (i.e. not able to read and write in local language)
- •Participation in another clinical trial
- •Unwillingness to accept the formula supplied by the study as the only formula for their child until the age of 12 months
- •Infants fed a special diet other than standard cow's or goat's milk based (non-hydrolyzed) infant formula prior to inclusion
研究组 & 干预措施
test formula
infant formula and follow-on formula with bioactive ingredients
干预措施: cows milk infant formula and follow-on formula with bioactive ingredients (Other)
control formula
standard infant formula and follow-on formula
干预措施: standard cows milk infant formula and follow-on formula (Other)
结局指标
主要结局
infection-related morbidity episodes, parent-reported
时间窗: 6 - 12 months of age
number of parental-reported respiratory and gut infection-related symptoms, compared between test and control group
weight
时间窗: until age of 6 months
weight for age, compared to WHO growth curve, for test group only
次要结局
- head circumference(until the age of 6 months)
- product tolerance: product intake(until the age of 6 months)
- product tolerance: GI comfort(until the age of 6 months)
- infection-related morbidity episodes, physician-diagnosed(6 - 12 months of age)
- weight(until the age of 6 months)
- length(until the age of 6 months)
- BMI(until the age of 6 months)
- product tolerance: stool frequency and consistency(until the age of 6 months)
- Duration of infection-related episodes(6 - 12 months of age)