跳至主要内容
临床试验/NCT00981877
NCT00981877已完成不适用

Probiotics in the Management of Acute Rotavirus Diarrhea in Bolivian Children: Randomized Double-blind, Controlled Trial Using Two Different Preparations

Centro Pediatrico Albina de Patino1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2007年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
76
试验地点
1
主要终点
Duration of diarrhea

研究概览

简要总结

The purpose of this study is to determine the effect of probiotics in rotavirus acute diarrhea in children. The investigators will compare the effect of two different probiotics products.

详细描述

Acute diarrhea remains being the second most frequent infectious condition in children, producing a high number of admissions yearly. In children below one year of age, rotavirus represents the main etiologic agent, both in developed and developing countries. In Bolivia, acute diarrhea affects about 30% of the group below 5 years of age. Probiotics appear as one of the alternatives currently under discussion. Also, evidence available suggests that probiotics shorten the time of diarrhea and therefore the time of rotavirus excretion. In daily practice, we are often limited by the type and number of probiotics products locally available; moreover, information about combined products is scarce. With this in mind, in this study we compared the efficacy of two commercially available products.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Care Provider, Investigator)

入排标准

年龄范围
1 Month 至 23 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Positive stool sample for rotavirus test

排除标准

  • Severe malnourishment
  • Severe dehydration
  • Use of antibiotics, probiotics or nitazoxanide 2 weeks before admission
  • Systemic infections
  • Severe chronic disease
  • Mixed enteric infections besides rotavirus

研究组 & 干预措施

1

Active Comparator

This group will receive S. Boulardii Probiotic and Oral rehydration as needed

干预措施: GB (Florestor) (Drug)

2

Active Comparator

This group will receive a mixed Probiotic preparation and oral rehydration as needed

干预措施: GRALB (Drug)

3

Placebo Comparator

This group will receive a placebo, and oral rehydration as needed

干预措施: GC (placebo) (Drug)

结局指标

主要结局

Duration of diarrhea

时间窗: within the first 72 hours during hospitalization

次要结局

  • Duration of vomiting(the first 72 hours during hospitalization)
  • Duration of hospitalization(4 days)
  • Duration of fever(the first 72 hours during hospitalization)

研究者

发起方
Centro Pediatrico Albina de Patino
申办方类型
Other

研究点 (1)

Loading locations...

相似试验