The Effect of Feeding Infant Formula With Bimuno Galactooligosaccharide (GOS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 392
- 主要终点
- Fecal bacteria analysis
研究概览
简要总结
This survey is a multicenter, double-blind, randomized, controlled, parallel-designed, prospective trial and is intended to evaluate the Bimuno GOS effects on growth, tolerance, gut health, fecal flora and immune function.
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
- 12 Days 至 18 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •o 15 ± 3 days of age at randomization, inclusive (day of birth is considered day 0)
- •Singleton birth
- •Gestational age of 37-42 weeks (36 weeks and six days is considered 36 weeks gestational age)
- •Birth weight of 2500g to 4000g
- •Signed informed consent obtained for infant's participation in the survey
- •Parent or guardian of infant agrees not to enroll infant in another interventional clinical research survey while participating in this survey
- •APGAR score after 5 minutes of life > 7
- •Consuming only one source of nutrition
- •Formula-fed infant: Infant consuming infant formula as the sole source of nutrition for 7 consecutive days prior to randomization
- •Breastfed infant: Infant consuming mother's breast milk as the sole source of nutrition for 7 consecutive days prior to registration
排除标准
- •Infant with inborn malformation and with hereditary and/or chronic and/or inborn diseases requiring hospital care superior to 7 days
- •Diseases jeopardizing intrauterine growth
- •Weight at Visit 1 is <95% of birth weight [(weight at Visit 1÷birth weight) x 100 <95%]
- •Infant born from mother suffering from metabolic and/or chronic diseases
- •Infant with an acute infection or gastroenteritis at time of randomization or registration
- •Infant consuming supplemental foods
- •Evidence of feeding difficulties or formula intolerance, such as vomiting or poor intake at time of randomization or registration
- •Infant is immunocompromised (according to a doctor's diagnosis of immunodeficiency such as Combined Immunodeficiencies, DiGeorge Syndrome, Wiskott-Aldrich Syndrome, Severe Congenital Neutropenia and Secondary Immunodeficiencies linked to HIV infection, Down Syndrome or others) and children with known head/brain disease/injury such as Microcephaly, Macrocephaly or others
研究组 & 干预措施
mother's breast milk.
mother's breast milk.
干预措施: Mother's breast milk (Dietary Supplement)
other GOS
Commercial infant formula containing 4% w/w FOS:GOS (1:3)
干预措施: GOS (Dietary Supplement)
B-GOS 3%
Commercial infant formula containing 3% w/w FOS:B -GOS (1:2)
干预措施: B-GOS 3% (Dietary Supplement)
B-GOS 2%
Commercial infant formula containing 4% w/w FOS:B -GOS (1:3)
干预措施: B-GOS 2% (Dietary Supplement)
结局指标
主要结局
Fecal bacteria analysis
时间窗: 6 months
o Fecal bacteria analysis of Bifidobacterium, Lactobacillus, Clostridium perfringens and Escherichia coli at the enrollment 30 days of age ,120 days of age and 180 days of age
Anthropometric parameters
时间窗: 6 months
body length, body weight, and head circumferences at enrollment (15± 3 days of age), 30, 60, 90, 120, 150 and 180 days of age
次要结局
- Formula intake(6 months)
- Saliva cortisol, IgA, chromogranin A and lysozyme(6 months)
- Fecal sIgA and SCFA analysis(6 months)
- Dietary(6 months)
- All medically confirmed adverse events and antibiotic record(6 months)