Double-blind, Randomized Placebo-controlled Trial Investigating Cumulative or Even Synergistic Effects of a Novel Prebiotic Combination in Healthy Toddlers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 342
- 试验地点
- 2
- 主要终点
- Absenteeism
研究概览
简要总结
The aim of this study is to demonstrate that a dietary supplementation with a novel prebiotic combination is safe, well tolerated and able to improve overall health of toddlers.
详细描述
The fermentation of a novel prebiotic combination leads to a modulation of the gut microbiota composition, in particular to a growth stimulation of bifidobacteria, and the production of organic acids like lactate and short-chain fatty acids (SCFA).The efficacy of the prebiotic combination to improve toddler's digestive function will be addressed. The overall health will be assessed as a measure of reduced number of febrile days resulting in less days of absenteeism from daycare centers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 10 Months 至 36 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Child is healthy at the time of pre-examination
- •Child is aged between 10-36 months and attends a day care center for the duration of the intervention
- •Child attends a daycare center at the time of pre examination for at least 50%.
- •Child presents a normal defecation characteristic (according to Brussels Infant and Toddler Stool scale)
- •Weight for height z-score >-2 and <2 SD based on Flemish growth charts
- •Child and legal guardian are able and willing to follow the study instructions
- •Child is suitable for participation in the study according to the investigator/ study personnel
- •Informed written consent given by parent / legal guardian
排除标准
- •No legal guardian's command of any local language
- •Child with any chronic disorder or disease, e.g., defecation disorders (incl. Hirschsprung and celiac disease) metabolic or renal abnormalities as well as mental or psychomotor retardation (incl. child´s mental delay and hypotonia)
- •Child is suffering from congenital or acquired immunodeficiency
- •Food allergies or intolerances
- •Child is currently breast-fed more than once daily
- •Use of drugs (e.g. antibiotics) influencing gastrointestinal function (6 weeks before intervention)
- •Use of laxatives (4 weeks before intervention) as well as probiotic and prebiotic food supplements. Follow-on formula with L. Reuteri and/or GOS/FOS/HMO is allowed.
- •Child is suffering from an infection at the time of pre examination or previous 7 days
- •Child is currently involved or will be involved in another clinical or food study
- •Child is not suitable for participation in the study according to the study personnel´s opinion
结局指标
主要结局
Absenteeism
时间窗: Data collected continuously from enrollment until end of intervention (up to 90 days).
Number of days of child´s absence from day care center due to infectious episodes or antibiotic treatment.
Fever
时间窗: Data collected continuously from enrollment until end of intervention (up to 90 days).
Number of febrile days (peak temperature of forehead at least 38.0°C)
次要结局
- Stool frequency(Data collected continuously from enrollment until end of intervention (up to 90 days).)
- Stool consistency(Data collected continuously from enrollment until end of intervention (up to 90 days).)
- Beneficial colonization(Stool sample collected at baseline and after 90 days intervention period)
- Caretaker´s absenteeism from work(Data collected continuously from enrollment until end of intervention (up to 90 days).)