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临床试验/NCT04525040
NCT04525040已完成不适用

Experience of Using ProbioKid for Children That Often Get Sick as a Prevention for Acute Respiratory Diseases

Lallemand Health Solutions0 个研究点目标入组 56 人开始时间: 2016年9月14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
56
主要终点
Number and duration of URTI and related complications

研究概览

简要总结

This study was designed to evaluate the preventive efficacy of a 6-week prophylactic administration of Probiokid® on the incidence of respiratory infections and related complications in frequently sick children.

详细描述

The microbiota is very important for the development of the immune system in children. Lactic acid bacteria, such as Lactobacillus and Bifidobacterium, are usually administered as probiotics (defined as live microorganisms that, when administered in adequate amounts, confer a health benefit on the host). Some probiotics were shown to sustain the development of immune competency in newborns, as well as to modulate the adaptive immune response and response to infections. For example, previous research suggests that probiotics decrease the incidence of upper respiratory tract infection (URTI). Probiokid® is a commercially-available formulation that consist of probiotics (Lactobacillus helveticus, Bifidobacterium infantis, Bifidobacterium bifidum) and fructooligosaccharides. This formulation has been shown to decrease the rate of respiratory infection in children supplemented for 3 to 9 months. Therefore the aim of this clinical trial is to assess the efficacy of Probiokid® supplemented for 6 weeks on the prevention of URTI and related complications among children (aged 3 to 10 years-old) that frequently suffer of acute respiratory infections. In addition, the impact of a prophylactic intervention with Probiokid® on the number of physician visits and antibiotic courses prescribed is assessed.

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
Single (Care Provider)

入排标准

年龄范围
3 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Age of children from 3 to 10 years,
  • High frequency of acute respiratory tract infections, characterized by a resistance index more than 0.33 (i.e. ARIs more often than once every 3 months).
  • Absence of other medications that affect the immune system in the treatment regimen (except for antibiotics, as per the care provider's judgment).

排除标准

  • Chronic pathological conditions.

结局指标

主要结局

Number and duration of URTI and related complications

时间窗: 6 months prior to enrollment, and 6 months follow-up

Difference between group in the change \[ follow-up - baseline\]

次要结局

  • Monthly incidence of URTI(6 months after the intervention)
  • Individual complication diagnosed (number of cases)(6 months prior to enrollment and 6 months after intervention)
  • Monthly number of visits to a specialized physician(6 months after the intervention)
  • Resistance index(6 months prior to enrollment and 6 months after intervention)
  • Number of antibiotics prescriptions(6 months prior to enrollment and 6 months after intervention)

研究者

发起方
Lallemand Health Solutions
申办方类型
Industry
责任方
Sponsor

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