NCT00858026已完成不适用
Impact of a Fermented Infant Formula in Weaning Babies
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bledina
- 入组人数
- 91
- 试验地点
- 9
- 主要终点
- To determine the impact of a fermented infant formula on the intestinal microbiota in weaning babies
研究概览
简要总结
When mothers wanted to shift from breast milk to infant formulae, babies were randomly assigned to receive a fermented or a standard formula. Biological and clinical investigations were achieved at baseline (V1), and after one (V2) and three months (V3) of consumption of study formula. Intestinal microbiota was assessed by using culture-dependent techniques.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 54 Days 至 68 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eutrophic infants, (± 2SD), healthy, male or female, of 2 months of age (± 1 week)
- •Born at 37 weeks of amenorrhea or more
- •Exclusively breastfed since birth
- •Written informed consent given by both parents (or tutors) for study participation
- •Parents (or tutors) agreeing on the follow-up by one of the study investigators
排除标准
- •Infant with congenital or acquired immunodeficiency, whatever the aetiology
- •Infant with a significant metabolic, organic or bowel disease which could interfere with the results of the present study,
- •Infant with congenital and/or chromosomal malformation,
- •Infant having received antibiotic therapy within the 3 weeks before the inclusion visit
- •infant receiving a treatment susceptible to interfere with the measure of study parameters
- •Antibiotic therapy per/pre/post partum > 48 h
- •Infant needing the prescription of a specific milk (HA, without cow milk)
- •Infant in a situation which could interfere with an optimal participation to the study, or which could represent a risk for the infant, according to the investigator.
结局指标
主要结局
To determine the impact of a fermented infant formula on the intestinal microbiota in weaning babies
时间窗: 2, 3 and 5 months of age
次要结局
- Compare the effect on enterobacteria and clostridium of a fermented formula vs. a standard formula toward the pursuit of breastfeeding(3 months of age)
- Describe the intestinal flora according to the nutrition group(3 and 5 months of age)
- Describe the growth, according to the nutrition group(3 and 5 months of age)
- Describe weight and height, current alimentation and potential infectious diseases since the visit at 5 months of age, according to the nutrition group(9 months of age)
- Describe the milk tolerance at the weaning according to the nutrition group(3 and 5 months of age)
- Describe the infection signs according to the nutrition group(3 and 5 months of age)
- Compare the effect on enterobacteria, clostridium and bifidobacteria of a fermented formula vs. a standard formula toward the pursuit of breastfeeding(5 months of age)
研究者
研究点 (9)
Loading locations...
相似试验
已完成
不适用
Impact of Infant Formula on Caregiver-perceived IntoleranceHealthy InfantsNCT03679234Société des Produits Nestlé (SPN)51
已完成
不适用
HYBRID: Hydrogen Breath Test in Lactose DigestionLactose IntoleranceNCT02703987Danone Asia Pacific Holdings Pte, Ltd.30
Unknown
不适用
Infant Formula Supplemented With Probiotic Microorganisms and/or Prebiotic.Focus on Healthy Infant Growth.NCT00836771Materna Laboratories270
进行中（未招募）
不适用
Transition to Infant Formula Feeding on Gastrointestinal Regurgitation (TIGER) StudyGastrointestinal Disorder, FunctionalRegurgitation, GastricColic, InfantileConstipation - FunctionalInfant DevelopmentNCT05363553Dairy Goat Co-operative (N.Z.) Limited146
Unknown
不适用
Effect of Early Feeding of Breast MilkWeight GainFeeding Disorder NeonatalNeonatal SEPSISNCT03498989Assiut University100