Possible Prophylactic Role of the S. Salivarius K12 Probiotic Strain for the Upper Respiratory Tract Infection and Nursery-age Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 287
- 试验地点
- 1
- 主要终点
- Incidence of any Gastrointestinal upset
研究概览
简要总结
The purpose of this retrospective study is to assess the treatment benefits of probiotic Streptococcus salivarius K12 for the prevention of recurrent bacterial and viral infections of the pharynx, tonsils and ears in children under 3 years of age.
详细描述
Recurrent bacterial and viral infections of the pharynx, tonsils and ears are a problem that can affect children of all ages. The persistence of these infections can lead to an overuse of drugs such as antibiotics, antipyretics and anti-inflammatories, with the possible consequent presence of side effects and above all an increase in antibiotic resistance, a global public health issue.
In search at reducing the use of antibiotics and antivirals, there is currently a great scientific interest in probiotic therapies for the oral cavity infection.
The aim of this retrospective, controlled, multicenter, non-profit study is to evaluate the efficacy and safety of the administration of Streptococcus salivarius K12 in pediatric patients attending the 1st or 2nd year of nursery school (< 3 years of age ), in the prophylaxis of the most common bacterial or viral respiratory infections, assessing the consequent reduction in the use of antibiotics, antivirals or other therapies compared to children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 3 Years(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy children attending the 1st or 2nd year of nursery (under aged 3 years)
- •Treated with probiotic Streptococcus salivarius K12 (1 billion CFU) for 90 continuous days
- •Children not treated with probiotic Streptococcus salivarius K12
排除标准
- •Children with underlying health condition
结局指标
主要结局
Incidence of any Gastrointestinal upset
时间窗: 03 Months
Safety and tolerability of the probiotic treatment
Bacterial or respiratory viral infection
时间窗: 03 Months
Evaluation of the frequency of bacterial or respiratory viral infection
Use of antibiotics or antivirals
时间窗: 03 Months
Evaluation of the frequency of use of antibiotic or antiviral therapies
次要结局
- Other pathologies(03 Months)
研究者
Dr. Amjad Khan
Professor
Liaquat University of Medical & Health Sciences
