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临床试验/NCT07168304
NCT07168304已完成不适用

Clinical Outcome of Zinc Plus Saccharomyces Boulardii Versus Zinc Alone in the Treatment of Acute Diarrhea in Children Under 5 Years of Age

Muhammad Aamir Latif1 个研究点 分布在 1 个国家目标入组 276 人开始时间: 2025年2月1日最近更新:
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
276
试验地点
1
主要终点
Resolution of vomiting

研究概览

简要总结

In literature combined therapy of zinc with S. boulardii in the treatment of acute diarrhea has not been addressed satisfactorily in the recent past. Therefore, this study was planned aiming to compare the mean time taken to resolve diarrhea and the mean time taken to resolve vomiting in children under 5 years of age having acute diarrhea with zinc plus S. boulardii versus zinc alone.

详细描述

Zinc has been used as a recommended choice treating acute watery ailments among children. If any significant beneficial effect in the combined efficacy of zinc with S. boulardii is found, it may add on to pre-existing knowledge and may lead clinicians to delineate the treatment guidelines to provide more effective treatment to the patients in clinical practices to reduce undesirable morbidity.

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
1 Month 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children of either gender
  • Aged between 1 month up to 5 years
  • Presented with acute diarrhea

排除标准

  • Children with concurrent acute illnesses (meningitis, sepsis, or pneumonia)
  • Severe chronic conditions (cystic fibrosis, endocrinopathies, food allergies, or chronic gastrointestinal diseases)
  • Severe undernutrition (weight-for-age <60% of the 50th percentile of CDC 2000 standards)
  • Children who used probiotics, antibiotics, or anti-diarrheal drugs within the past 7 days
  • The presence of visible blood in stools

研究组 & 干预措施

Probiotic group

Experimental

Standard treatment plus S. boulardii

干预措施: S. boulardii (Drug)

结局指标

主要结局

Resolution of vomiting

时间窗: 14 hours

The time from the start of treatment to the last episode of vomiting.

Resolution of diarrhea

时间窗: 7 days

The duration from initiation of treatment until passage of normal stools (Bristol Stool Form Scale types 3-4).

次要结局

未报告次要终点

研究者

发起方
Muhammad Aamir Latif
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Muhammad Aamir Latif

Research Consultant

RESnTEC, Institute of Research

研究点 (1)

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