The Effect of Probiotics in Reducing Infections and Allergic Manifestations in Young Children During the Complementary Feeding Period
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Number of days absent from day care due to respiratory and gastrointestinal infections
研究概览
简要总结
The aim of the intervention is to examine the effect of the bacterial strain BB-12, provided for 6 mo, on the prevalence of infections and allergic manifestations in small children, and how BB-12 affects the immune system, the gastrointestinal tract and the microbiota. Children are enrolled during 2 winter seasons.
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
- 9 Months 至 13 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •9 - 12 1/2 month at intervention start
- •Start in daycare 4 +/- 2 weeks after intervention start
- •Single born
排除标准
- •Children born before 37th gestational week
- •Children with a birth weight < 2500 g
- •Children suffering from severe chronic illness
- •Children receiving regular medication
- •Children who have received antibiotics within a month before intervention start
- •Children whose parents do not speak Danish
研究组 & 干预措施
probiotic (10^9 cfu/day)
Daily intake of bifidobacterium animalis ssp. Lactis (BB12), 10^9 cfu/day, provided as powder in a sachet which can be added to food or drink.
干预措施: Probiotic (10^9 CFU/day) (Dietary Supplement)
probiotic (10^8 cfu/day)
Daily intake of bifidobacterium animalis ssp. Lactis (BB12), 10^8 cfu/day, provided as powder in a sachet which can be added to food or drink.
干预措施: Probiotic (10^8 CFU/day) (Dietary Supplement)
Placebo
provided as powder in a sachet which can be added to food or drink.
干预措施: Placebo (Other)
结局指标
主要结局
Number of days absent from day care due to respiratory and gastrointestinal infections
时间窗: Up to 6 month
Recorded weekly by the parents using web-based questionnaires
次要结局
- Acute lower respiratory infections(Up to 6 month)
- Acute upper respiratory tract infections(Up to 6 month)
- Gastrointestinal infections(Up to 6 month)
- Fever(Up to 6 month)
- Antibiotic use(Up to 6 month)
- Allergies(Up to 6 month)
- Absence from day care due to illness other than infections(Up to 6 month)
- Parental absence from work due to illness of the child(Up to 6 month)
- Medical visits(Up to 6 month)
- Change from baseline in Thymus size(At baseline and after 6 mo (end of intervention))
研究者
Arne Astrup
Professor
University of Copenhagen