Bifidobacterium Lactis BB12 and Xylitol Delivered With a Novel Slow-release Pacifier
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 2
- 主要终点
- MS colonization
研究概览
简要总结
Aims:
- To develop a food supplement containing a health-promoting probiotic bacteria (B. lactis BB12) and xylitol to be administered with a novel soft, possibly occlusion-friendly pacifier.
- Test in a clinical study how feasible the method is and to study how the intervention affects caries occurrence.
Main hypothesis:
The administration of B. lactis BB12 and xylitol affects beneficially the dental health of the child.
详细描述
Xylitol is known to reduce counts of mutans streptococci (ms) as well as mother-child transmission of ms. Possibly xylitol delivered to infants could positively influence colonization/metabolism of ms. By combining in a food supplement xylitol and B. lactis BB12 (a well known probiotic bacteria) we may be able to positively affect both gut and oral colonization, reflected in both dental and general health (solid data available on the latter aim). Though B. lactis is in wide use in baby formulas and in in vitro tests it apparently is safe for the teeth, no clinical studies have looked at effects of its administration to infants on oral health. Our study aims to look at caries occurrence in infants who have received the xylitol + BB12 food supplement with a pacifier.
Recruiting of subjects to the study is completed.
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
- 1 Month 至 4 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The infant is healthy
- •The family agrees to use the novel slow-release pacifier
- •The infant starts to use the pacifier before the age of 3 months
排除标准
- •The child is not healthy
结局指标
主要结局
MS colonization
时间窗: 2 years
次要结局
- Acute infectious diseases(2 years)
- Caries occurrence(4 years)
研究者
Eva Soderling
Associate professor
University of Turku