NCT00760851已完成3 期
Study to Investigate the Potential of Probiotics II
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 190
- 试验地点
- 2
- 主要终点
- To determine if consumption of a yogurt drink containing Bb-12 decreases the number of absences children have from daycare/school due to illness
研究概览
简要总结
The purpose of this study is to determine the effectiveness of probiotics (popularly referred to as 'live active culture' or 'good bacteria') in preventing illnesses and consequent absences from school/daycare centers of children two to four years old that attend daycare at least 3 days per week. Two yogurt drinks will be administered, one containing a specific strain of probiotic, Bb-12. It is hypothesized that children receiving the Bb-12 drink will experience fewer illnesses and absences from daycare.
In this study, participants will be asked to:
- Give their child 4 oz. of the test yogurt each day for 90 days
- Keep a daily diary of their child's health
- Collect 3 stool samples from their child at the start, middle, and end of the study
- Speak with research personnel on a bi-weekly basis regarding their child's health
- Ensure that their child to consume any yogurts or probiotic-containing products for 110 days of the study
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
- 2 Years 至 4 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Child aged 2 to 4 years of age
- •Child attends daycare at least 3 days per week
排除标准
- •Caregiver does not speak English or Spanish
- •Caregiver does not agree to have their child refrain from cultured dairy products (yogurt) for the 105-day duration of the study
- •Caregiver does not agree to collect a stool sample from their child on Day 0, 45, and 105 of the study
- •Caregiver does not have a refrigerator to store the yogurt product at home
- •Child is currently receiving breast milk
- •Child has an allergy or hypersensitivity to milk proteins or other dairy food components such as lactose
- •Child has an allergy or hypersensitivity to strawberry or red food coloring
- •Child has a chronic disease
- •Child has had an infection or been sick 7 days prior to starting study
- •Child has had diarrhea or constipation 7 days prior to starting study
- •Child has a special diet as prescribed by a medical professional
- •Child has received antibiotics, antiseptics, antifungal, corticosteroids, anti-histamines, non steroidal anti-inflammatory drugs within 7 days prior to starting the study
- •Child has a congenital anomaly or birth defect that requires medical care
结局指标
主要结局
To determine if consumption of a yogurt drink containing Bb-12 decreases the number of absences children have from daycare/school due to illness
时间窗: 90 days
次要结局
- Determine if the yogurt supplemented with Bb-12 results in overall improved parental satisfaction due to decreased illnesses in children attending daycare/school(90)
研究者
研究点 (2)
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