跳至主要内容
临床试验/NCT06540209
NCT06540209已完成不适用

Comparison of Effectiveness of Zinc Supplementation With ORS and Bacillus Clausii Versus Zinc With ORS and Saccharomyces Boulardii in Acute Watery Diarrhea in Paediatric Patients

RESnTEC, Institute of Research1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Stool frequency

研究概览

简要总结

The current study was carried out to directly compare the effectiveness of zinc supplementation with ORS and Bacillus clausii versus zinc with ORS and Saccharomyces boulardii among the local pediatric population presenting with acute watery diarrhea.

详细描述

The results and importance of effective treatment for acute watery diarrhea in pediatric patients vary throughout the world. Previously, very limited literature was available comparing the efficacy of Bacillus clausii and Saccharomyces boulardii in acute watery diarrhea, providing mixed results. The current study aims to directly compare the effectiveness of zinc supplementation with ORS and Bacillus clausii versus zinc with ORS and Saccharomyces boulardii.

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
None

入排标准

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

入选标准

  • Patients of either gender
  • Aged 3 months to 5 years
  • With acute watery diarrhea last less fewer than 14 days
  • Presenting with mild to moderate dehydration

排除标准

  • Patients with a history of blood or pus in their stools
  • History of recent antibiotic or probiotic treatment
  • Patients with immunodeficiency conditions, acute systemic illnesses, or chronic diarrhea
  • Patients with hypersensitivity to Bacillus clausii or Saccharomyces boulardii

研究组 & 干预措施

Saccharomyces boulardii +zinc+ ORS group

Experimental

Patients were given zinc with ORS and Saccharomyces boulardii

干预措施: ORS (Drug)

Bacillus clausii + zinc+ ORS group

Experimental

Patients received zinc supplementation with ORS and Bacillus clausii

干预措施: Bacillus clausii (Drug)

Bacillus clausii + zinc+ ORS group

Experimental

Patients received zinc supplementation with ORS and Bacillus clausii

干预措施: Zinc (Drug)

Bacillus clausii + zinc+ ORS group

Experimental

Patients received zinc supplementation with ORS and Bacillus clausii

干预措施: ORS (Drug)

Saccharomyces boulardii +zinc+ ORS group

Experimental

Patients were given zinc with ORS and Saccharomyces boulardii

干预措施: Saccharomyces boulardii (Drug)

Saccharomyces boulardii +zinc+ ORS group

Experimental

Patients were given zinc with ORS and Saccharomyces boulardii

干预措施: Zinc (Drug)

结局指标

主要结局

Stool frequency

时间窗: 5 days

Number of stools per day

Stool consistency

时间窗: 5 days

Graded on a five-point scale as firm, soft, thick liquid, opaque watery, and watery

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验