Effects of the Supplementation With Oligosaccharides on the Prevention of Infections in Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 8
- 主要终点
- Incidence of infections during first year of life
研究概览
简要总结
The primary objective of the present study was to evaluate the effects of long-term supplementation of an infant formula supplemented with prebiotic inulin-type oligosaccharides on immunological-health related outcomes.
详细描述
The study primarily aimed to evaluate the effects of long-term supplementation of an infant formula with a mixture of short and long chain inulin-type oligosaccharides on immunological-health related outcomes, as well as on gastrointestinal function and well-being in infants during the first year of life. Effects on infant growth, tolerance and on the composition of fecal microbiota were further objectives of this study. The study was conducted as a multicenter, randomised, double-blind, placebo-controlled study in healthy term infants. The two groups of the study are product group (standard infant formula supplemented with inulin-type fructans) and control group (non-supplemented standard infant formula).
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
- 1 Day 至 4 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy babies born between 37 - 42 weeks of gestation and with weight appropriate for gestational age (between percentiles 3 and 97)
- •Healthy babies aged between 0 - 4 months of age
- •Babies exclusively fed with an infant formula on enrolment into the study
排除标准
- •The presence of an infection at the moment of the recruitment or 1 week before recruitment
- •The presence of important pathologies (intestinal, cardiopathy, mental retardation, etc.)
- •Any other diseases related to the immune system (primary immunodeficiency)
- •Parents not able to comply with the study follow up (according to physician criteria)
结局指标
主要结局
Incidence of infections during first year of life
时间窗: until infant reaches age of 1 year
measured through presence of fever, and number and duration of infectious episodes
次要结局
- Stool frequency(until infant reaches age of 1 year)
- Body height(until infant reaches age of 1 year)
- Crying episodes(until infant reaches age of 1 year)
- Stool consistency(until infant reaches age of 1 year)
- Sleeping habits(until infant reaches age of 1 year)
- Effect on fecal microbiota composition(until infant reaches age of 1 year)
- Digestive tolerance(until infant reaches age of 1 year)
- Growth(until infant reaches age of 1 year)
- Body weight(until infant reaches age of 1 year)
- Head circumference(until infant reaches age of 1 year)
- Effect on development of allergy(until infant reaches age of 1 year)
- Effect on immunology markers in feces(until infant reaches age of 1 year)