Suitability of an Infant Formula With Reduced Protein Content Based on a Partial Respectively an Extensive Proteinhydrolysate With and Without Pro- and Prebiotics for the Particular Nutritional Use by Infants.-Extension by 4 Year Follow-up
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 503
- 试验地点
- 5
- 主要终点
- average weight gain
研究概览
简要总结
The study is conducted to examine the suitability of partially respectively extensively hydrolyzed low protein infant formulae with and without pro- and prebiotics for healthy, term infants.
Primary hypothesis to be tested is: an infant formula based on a Protein hydrolysate with modified protein content is non inferior compared to a standard infant formula based on a Protein hyrolysate in respect to proper growth of healthy, term infants within the first four month of life.
4-year follow-up (without further Intervention) will focus on body composition and allergic predisposition.
详细描述
View Section Brief Summary
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 1 Day 至 27 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •written informed consent (by parents, caregiver)
- •Healthy term newborns (gestational age: ≥ 37 weeks)
- •Birth weight between 2.500 - 4.500 g
- •Age at enrolment: < 28 days of age
- •Infant received no other formula since birth
- •Parents / Caregivers are able to speak German
排除标准
- •Severe acquired or congenital illness
- •preterm infants (gestational age < 37 weeks)
- •Birth weight lower than 2.500 g or higher than 4.500 g
- •Feeding a cows milk based formula or any other formula prior to inclusion in this study
- •Participation in any other clinical study intervention
- •Regular intake of supplementary pre- and probiotics by the child and/or breastfeeding mother
- •Mothers with diabetes mellitus or mothers suffered from gestational diabetes
- •Founded assumption that it will not be possible for parents / caregivers to be compliant with the study protocol
- •Breastfed infants: illness of the mother, that may have an influence on the gastrointestinal tract of the child
- •Breastfed infants: mother receives or received antibiotics one week before inclusion in this study or during the first study phase
研究组 & 干预措施
control formula group
infants are fed a commercial, hydrolysed formula during the first 4 month of life, according to protocol
干预措施: control formula (Other)
intervention formula 1 group
infants are fed hydrolyzed infant formula with different protein content during the first 4 month of life, according to protocol
干预措施: intervention formula 1 (Other)
intervention formula 2 group
infants are fed hydrolyzed infant formula with different protein content with pro- and prebiotics during the first 4 month of life, according to protocol
干预措施: intervention formula 2 (Other)
intervention formula 3 group
infants are fed hydrolyzed instant formula with different protein content with pro- and prebiotics during the first 4 months of life, according to protocol
干预措施: intervention formula 3 (Other)
Reference group
infants are breast fed
结局指标
主要结局
average weight gain
时间窗: 4 months
The intervention is to assess average weight gain in the first 4 months of life.
次要结局
- Anthropometric data at age of 4 years(4 years)
- Body composition (Skin fold) at age of 4 years(4 years)
- Body composition (fat mass, lean body mass) at age of 4 years(4 years)
- allergic sensitization and symptoms(12 months)
- Allergic predisposition at age of 4 years by measuring specific IgE in blood(4 years)