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临床试验/NCT05840926
NCT05840926已完成不适用

Possible Prophylactic Role of the S. Salivarius K12 Probiotic Strain for the Upper Respiratory Tract Infection and Nursery-age Children

Liaquat University of Medical & Health Sciences1 个研究点 分布在 1 个国家目标入组 287 人开始时间: 2022年1月5日最近更新:
适应症

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

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

发起方
Liaquat University of Medical & Health Sciences
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Amjad Khan

Professor

Liaquat University of Medical & Health Sciences

研究点 (1)

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