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临床试验/NCT02407106
NCT02407106Unknown不适用

Efficacy of Streptococcus Salivarius BLIS (Bacteriocin-like Inhibitory Substance) K12 as Preventive Measure for Rheumatic Children.

Kaplan Medical Center0 个研究点目标入组 30 人开始时间: 2015年9月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
30
主要终点
number of Strep throat infections while in study

研究概览

简要总结

The purpose of this study is to determine whether daily treatment with Streptococcus Salivarius BLIS K-12 prevents streptococcal throat infection in children that have had an episode of rheumatic fever.

详细描述

Children diagnosed with Rheumatic fever are currently given preventive streptococcal treatment with either monthly IM (intramuscular injection) Penicillin or daily oral Penicillin.

This preventive treatment is recommended for years until the child is 20 y old or even later. The compliance rate for this treatment declines significantly with time (the injections are painful) and even with good adherence the prevention is not complete.

In the last few years a new product licensed as "BLIS K-12" has been developed and approved by FDA as GRAS (generally recognized as safe) status from 2011.

This probiotic treatment prevents the pathogenic Strep A from adhering to the throat of the child thus preventing the infection. This kind of prevention is better for the long run for the patient and for the surrounding, It is better tolerated, is effective even if a dose is skipped or missed is not painful and is tasty to the children.

So the investigators assumption is that giving this product to children instead of Penicillin either orally or intramuscularlly will be better tolerated thus give a better protection profile with much less side effects.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
6 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Rheumatic heart disease with recommended strep prophylaxis

排除标准

  • less than one year from first diagnosis
  • refusal to take the tablets

结局指标

主要结局

number of Strep throat infections while in study

时间窗: six month

次要结局

未报告次要终点

研究者

发起方
Kaplan Medical Center
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Yael Garty MD

MD

Kaplan Medical Center

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