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临床试验/NCT00492583
NCT00492583已完成3 期

Study to Investigate the Potential of Probiotics in Yogurt

Georgetown University1 个研究点 分布在 1 个国家目标入组 182 人开始时间: 2007年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
182
试验地点
1
主要终点
Number of Days Children Are Out of School Sick

研究概览

简要总结

The purpose of this study is to determine if the consumption of a yogurt drink containing a high dose of probiotics decreases absences, due to illnesses, in daycare centers for children between the ages of 1 and 3.

详细描述

It is reported that more than half of all young children attend daycare centers in the United States. Absences due to illnesses are costly both on an individual and societal level; these absences are generally due to diarrhea or upper respiratory infections.

In the U.S., children under five years of age experience 20-35 million episodes of diarrhea per year. These episodes lead to 2-3.5 million physician visits (which account for 10% of all visits by children), more than 200,000 hospitalizations (13% of hospital admissions in children under five years), and 325-425 deaths annually. In 1991, the outpatient costs of treating diarrhea in children under age three was calculated at 0.6-1 billion dollars per year.

Respiratory illness is among the leading causes of death in children under five years of age. Approximately 200,000 deaths in the U.S. and 3.9 million deaths worldwide are attributed to respiratory illnesses. Respiratory illness is also the most frequent reason for physician consultation, with more than 40% of all pediatric outpatient visits related to respiratory illness. According to a recent study, 39% of children attending daycare experienced acute otitis media (ear infection) and 26% reported allergies. Most notably, 10% of children attending daycare were admitted to the hospital due to respiratory illnesses.

We have chosen BB-12 as the probiotic for this study as it is one of the best characterized probiotics with a long safety record in children, a well-proven ability to colonize the human intestinal tract, and demonstrated efficacy for different pediatric conditions. Furthermore, BB-12 is a commercially available probiotic strain that has been used in a number of feeding and clinical trials.

In fact, there is a new infant formula on the market, using the identical strain we are, in the first commercially available probiotic infant formula available in the United States. Not only has BB-12 been found to survive transit through the stomach, small intestine and colon, but also long-term consumption of BB-12 formula at levels as high as 1 billion CFU/g (240 g serving) have been found to be safe.

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 Year 至 3 Years(Child)
性别
All
接受健康志愿者

入选标准

  • attending daycare or preschool centers at least 3 days a week
  • male or female
  • parents must speak English or Spanish
  • subjects or parents/legal guardians who agree to have their child refrain from consuming any other yogurts or foods containing probiotics for the duration of the study

排除标准

  • subjects with developmental delays
  • subjects with chronic conditions such as diabetes or asthma that require daily medication
  • subjects with birth weight <2500 grams
  • subjects with strawberry allergies
  • subjects with active diarrhea
  • subjects with congenital anomalies
  • subjects with failure to thrive
  • subjects with parental belief of lactose intolerance

研究组 & 干预措施

Placebo

Placebo Comparator

Subjects were provided 4 fluid ounces (112 grams) administered orally per day of placebo drink.

干预措施: Placebo (Drug)

Bifidobacterium lactis (BB-12)

Experimental

Subjects were provided 4 fluid ounces (112 grams) administered orally per day of active drink.

干预措施: Bifidobacterium lactis (BB-12) (Drug)

结局指标

主要结局

Number of Days Children Are Out of School Sick

时间窗: 90 days

Outcome measure, "number of days children are out of school sick" was measured for the entire population

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (1)

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