NCT02031887终止不适用
Effect of a Starter Formula With Synbiotics on Stool Microbiota in Infants After Normal or Caesarean Section Delivery
Société des Produits Nestlé (SPN)6 个研究点 分布在 1 个国家目标入组 430 人开始时间: 2008年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 430
- 试验地点
- 6
- 主要终点
- differences in the colonization of the gastrointestinal tract with the bacteria Bifidobacterium sp. between infants born by normal or caesarean delivery, fed with the test or a control product
研究概览
简要总结
The primary objectives of this trial are:
- to show differences in the colonization of the gastrointestinal tract with the bacteria Bifidobacterium sp. between infants born by normal or caesarean delivery, fed with the test or a control product
- to investigate whether there is equivalence in growth between the four different groups of infant described above.
详细描述
The primary objectives of this trial are:
- to show differences in the colonization of the gastrointestinal tract with the bacteria Bifidobacterium sp. between infants born by normal or caesarean delivery, fed with the test or a control product
- to investigate whether there is equivalence in growth between the four different groups of infant described above.
Design:
This is a controlled, double blind, randomized, multi center, clinical trial of 4 groups in parallel.
Two groups of infants (born from normal or caesarean delivery) will each consume one of 2 milk formulae.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 3 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy newborn infant from HIV positive mother
- •Full term infant (more or equal to 37 weeks gestation; less or equal to 42 weeks gestation)
- •Age of infant 3 days at the time of enrollment
- •Birth weight between 2500 and 4500 grams
- •Singleton birth
- •The infant's mother has elected to feed their child exclusively with a milk formula from birth
- •Informed consent from the parent or legal guardian
排除标准
- •Congenital illness or malformation that may affect normal growth
- •Significant pre-natal and / or post-natal disease
- •Newborns who have received antibiotics during the first 3 days of life
- •Newborns whose parents / caregivers cannot be expected to comply with the study protocol
- •Newborns currently participating in another clinical trial
结局指标
主要结局
differences in the colonization of the gastrointestinal tract with the bacteria Bifidobacterium sp. between infants born by normal or caesarean delivery, fed with the test or a control product
时间窗: 3 days, 10 days, 1 month, and 3 months of age of the infant
• Mean weight gain (g/day)
时间窗: over 112 days
次要结局
- body composition by DEXA(4 month and 12 month of life)
- Digestive tolerance (stool characteristics and frequency, vomiting, regurgitation, frequency of colic)(10 days, 1 month, 6 weeks, 3 month and 4 month of life)
研究者
研究点 (6)
Loading locations...
相似试验
已完成
不适用
Effect of Starter Formula on Infection PreventionGastro-intestinal InfectionsInfections With FeverNCT01880970Société des Produits Nestlé (SPN)477
已完成
2 期
Symbiotic & ColonizationHealthyNCT01983072Société des Produits Nestlé (SPN)141
已完成
不适用
Effect of a Synbiotic on the Gut Microbiota and Adiposity-related Markers in Healthy Overweight SubjectsGut MicrobiotaAdiposityNCT02151825Texas State University, San Marcos54
已完成
不适用
Synbiotics and Gastrointestinal Function Related Quality of Life After Colectomy for CancerColorectal NeoplasmsNCT01479907University of Athens100
招募中
不适用
Evaluating the Effects of a Synbiotic Versus Probiotic or Placebo on Gut Microbiota and Cardiometabolic Health: A Randomized Double-Blind Placebo Controlled TrialBlood Pressure, Body Composition, Immune FunctionNCT06544915Skidmore College60