NCT01424852撤回不适用
Early Administration of Bifidobacterium Lactis BB-12 and the Caries Occurence of Children a 4 Years of Age
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Caries occurence
研究概览
简要总结
Aim: to examine caries occurrence in children who ten years ago received a mixture of probiotics during infancy.
Hypothesis: the administration of probiotics during infancy has no effect on future dental health.
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 Years 至 12 Years(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Child participated in the probiotic milk intervention study in early 2000
- •Child lives now within 100 km from Turku
排除标准
- •Child has a chronic illness affecting dental health
- •Child lives now outside 100 km from Turku
研究组 & 干预措施
Probiotics in milk formula
Active Comparator
B. lactis BB-12 and L. rhamnosus GG delivered in milk formula during the first year of infancy
干预措施: Probiotics in infant milk formula (Dietary Supplement)
Control milk formula
Placebo Comparator
The children received milk formula with no probiotics
干预措施: Probiotics in infant milk formula (Dietary Supplement)
结局指标
主要结局
Caries occurence
时间窗: 10 years
次要结局
- Oral microbial colonization(10 years)
研究者
Eva Soderling
Adjunct Professor
University of Turku
研究点 (1)
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