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临床试验/NCT02558192
NCT02558192已完成3 期

Administration of a Lactobacillus GG and Vitamins Containing Mixture is Effective in Preventing Nosocomial Infection in Children

Federico II University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2014年1月1日最近更新:
适应症
干预措施

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
90
试验地点
1
主要终点
Study the incidence of nosocomial gastrointestinal infection

研究概览

简要总结

Nosocomial infections are infections that occur from the time of 'entry in the hospital up to 48h after discharge. In most developed countries, the incidence of nosocomial infections in children is between 5% and 44% with the predominance of respiratory infections and gastrointestinal infections. Nosocomial infections prolong the time of hospital stay, reduce the effectiveness of treatment, significantly increasing hospital costs. Current measures for prevention of nosocomial infections in pediatrics, such as vaccinations and compliance with sanitary regulations, are not fully effective. Therefore it is necessary a deepening of the possible methods of prevention, between which has been already tested the use of probiotics such as Lactobacillus GG. A recent RCCT, which provided for the administration of LGG against placebo, noted a significant reduction in the risk of gastrointestinal infections and respiratory infections in hospitalized children treated with LGG, compared with patients who received placebo. There are also evidence which demonstrate a potential role zinc in reducing the incidence of respiratory infections is that bowel. We thought, therefore, to perform a multicenter randomized controlled trial with the aim to evaluate the role of a complex containing LGG, vitamins and zinc in the prevention of nosocomial gastrointestinal and respiratory tract infections in pediatric wards.

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
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
3 Months 至 5 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Males and females between the ages of 3 months and 5 years
  • •Children admitted to a pediatric ward

排除标准

  • •Children with chronic diseases of the respiratory , gastrointestinal , renal system;
  • •Children with malformations of the cardiovascular system ;
  • •Children with immune deficiencies ;
  • •Infants born preterm ( gestational age < 37 weeks ) ;
  • •Children with congenital metabolic diseases ;
  • •Children Who received probiotics before enrollment ( up to 7 days before hospitalization)

研究组 & 干预措施

Placebo

Placebo Comparator

Vials containing water, maltodextrin, magnesium stearate, potassium sorbate, sodium benzoate, citric acid, fructose, flavor.

干预措施: PLACEBO (Dietary Supplement)

Probiotics

Experimental

Vials containing 3 x 10^9 Colony Forming Units of LGG, vitamins ( B and C) and zinc

干预措施: Lactobacillus Rhamnosus GG (Dietary Supplement)

结局指标

主要结局

Study the incidence of nosocomial gastrointestinal infection

时间窗: After 15 days of treatment

Study the incidence of nosocomial URTI

时间窗: After 15 days of treatment

次要结局

  • Days of hospitalization(After 3 months from the enrollment)
  • The incidence of gastrointestinal and respiratory infection during the 3 month follow-up period(After 3 months from the treatment)

研究者

发起方
Federico II University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alfredo Guarino

Full Professor of Pediatrics

Federico II University

研究点 (1)

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