NCT00653705已完成不适用
The Effect of Daily Consumption of Yogurt Containing Bifidobacterium Lactis (BB12) on Children's' Health and Child Care Absenteeism
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 181
- 试验地点
- 2
- 主要终点
- Days of illness symptoms, number, duration and severity of illness episodes, day care absenteeism, and parental work absenteeism
研究概览
简要总结
The aim of our study is to assess the effect of daily consumption of yogurt containing probiotic bacteria BB12 on the health and growth of healthy children 12-48 months of age in out of home child care.
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
- 12 Months 至 48 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •An informed consent has been signed by the parents.
- •The child is at least one year old and has not had his 4th birthday at the beginning of the study
- •The child is healthy.
- •The child attends child care center at least 5 days a week, > 4 hours per day.
排除标准
- •Was born preterm.
- •Had a birth weight <2,500 g.
- •Has congenital anomalies.
- •Has a structural abnormality of the digestive tract or previous significant gastrointestinal surgery.
- •Has chronic disease or malignancy.
- •Has a serious, unstable medical condition.
- •Is Failure to Thrive (FTT) (<5th percentile of ideal body weight).
- •Has an allergy or atopic disease.
- •Has an allergy or intolerance to milk/dairy products.
- •Has an established diagnosis of lactase deficiency.
- •Is predisposed to infection (i.e., compromised immune system, HIV-AIDS, active bacterial disease, under steroid treatment).
- •Received antibiotic treatment or intentionally consumes probiotic products during the preceding 4 weeks. (If the subject was on antibiotics before the beginning of the study or probiotics, a washout period of 2 weeks is required.)
结局指标
主要结局
Days of illness symptoms, number, duration and severity of illness episodes, day care absenteeism, and parental work absenteeism
时间窗: 16 weeks
次要结局
- Health care utilization and illness related costs as measured by number of physician visits, ER visits, hospitalizations, and antibiotics use. Also, child growth and quality of life. Exploratory biomarker outcomes in stool.(16 weeks)
研究者
Tamar Ringel-Kulka, MPH
Assistant Professor, Maternal and Child Health
University of North Carolina, Chapel Hill
研究点 (2)
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