NCT00836771Unknown不适用
Evaluation of the Effect of Milk Based Infant Formula Supplemented Either With Probiotic Microorganisms and/or With Prebiotic on the Intestinal Microflora During the First 4 Months of Life of Healthy, Full Term Infants and it's Long Term Effect on Morbidity up to the Age of 9 Months
Materna Laboratories1 个研究点 分布在 1 个国家目标入组 270 人开始时间: 2009年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 270
- 试验地点
- 1
- 主要终点
- weight gain
研究概览
简要总结
Evaluation the nutritional suitability of a based milk infant formula supplemented with friendly bacteria (probiotic microorganisms) and or nutritional fibers (prebiotic) to healthy, full term infants compare with an otherwise identical widely used commercially available milk based infant formula and/or breast feed
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Day 至 21 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy term infants of both sexes, born in natural labor .
- •Single birth.
- •Full term infants (born between the 37th and 42nd week of gestation)
- •Infants with birth weight >2500 g.
- •Recruitment age will be 0-21 days.
- •Infants whose mothers are unable to breast feed or have chosen not to breast feed prior to the study enrollment.
- •Infants whose parents have agreed to participate in the study up to the age of 9 months..
- •Infants whose parents have agreed to remain exclusively on the same product for 16 weeks of age..
- •Infants whose parents have signed the informed consent form.
- •Infants whose parents are able to understand the protocol requirements and to fill out the infant's diary and agree to completely fill out the parents' questionnaires during the period Of 9 months
排除标准
- •Premature or low birth weight (< 2500 g).
- •Chromosomal abnormalities or congenital malformation.
- •Suffering jaundice which require phototherapy.
- •Proven or suspected family history of allergy to cow's milk.
- •Having been treated with antibiotics or other drugs during the last three days or more prior to the commencement of the study.
结局指标
主要结局
weight gain
时间窗: 1 to 120 days of age
次要结局
- Anthropometric(1-120 days of age)
- GI tolerance(1-120 days of age)
研究者
研究点 (1)
Loading locations...
相似试验
进行中（未招募）
不适用
Evaluation of an Adapted Formula on Atopic Dermatitis.Atopic DermatitisNCT05318300United Pharmaceuticals126
已完成
不适用
Formula With Modified Content of Protein and Improved Fatty Acids and Their Impact on Infant Growth and HealthInfant NutritionNCT01094080Ludwig-Maximilians - University of Munich505
已完成
不适用
Infant Formula Supplemented With a Special Fat Formulation for Premature Infants Following Discharge From HospitalPremature InfantsNCT01140243Materna Laboratories31
Unknown
不适用
Effect of a New Infant Formula With Specific IngredientsInfant GrowthNCT04306263Laboratorios Ordesa231
已完成
不适用
Effects of an Infant Formula on Growth, Safety and Efficacy for Healthy Term InfantsInfant DevelopmentNCT04749290Bunge Loders Croklaan180