Efficacy and Safety of Saccharomyces Boulardii in Treatment of Acute Diarrhea in Children Aged 6 Months to 5 Years Old
2026年9月8日 更新者：Nguyễn Thị Phương Thão、Can Tho University of Medicine and Pharmacy
This study aimed to evaluate the effectiveness of saccharomyces-based treatment in children with acute diarrhea aged 6 months to 5 years compared to children treated with standard methods.
研究概览
地位
尚未招聘
条件
详细说明
A total of 206 children diagnosed with acute diarrhea will be evaluated and divided into two groups based on a random distribution list: Group A and Group B.
Group A will be treated with standard methods including fluid replacement and zinc according to the Ministry of Health's protocol.
Group B will be treated similarly to Group A, but with the addition of Saccharomyces boulardii at a dose of 250 to 750 mg per day until discharge.
Both groups of children will receive the same counseling and monitoring, with guidance provided to parents.
Caregivers are advised to record symptoms and stool diaries daily.
研究类型
介入性
注册 (估计的)
206
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Thao Thi Phuong Nguyen, M.D
- 电话号码：+84789212603
- 邮箱：Whynottheo@gmail.com
研究联系人备份
- 姓名：Duc Long Tran, Ph.D
- 邮箱：tdlong@ctump.edu.vn
学习地点
-
-
-
Can Tho、越南、900000
- Can Tho University of Medicine and Pharmacy
-
接触：
- Duc Long Tran, Ph.D
- 电话号码：+842923739730
- 邮箱：tdlong@ctump.edu.vn
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-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
接受健康志愿者
是的
描述
Inclusion Criteria:
- Age from 6 months to 5 years old
- Children are diagnosed with acute diarrhea according to WHO criteria.
Exclusion Criteria:
- Bloody, mucous stools.
- Signs of sepsis requiring admission to the Intensive Care Unit.
- Currently suffering from chronic diseases such as cow's milk protein allergy, nephrotic syndrome, immunodeficiency, and systemic diseases.
- Currently using immunosuppressant drugs.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Saccharomyces boulardii
Saccharomyces boulardii is a type of yeast that helps to quickly restore the intestinal mucosal barrier and the gut microbiome, significantly shortening hospital stays.
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Children will receive standard treatment including fluid and zinc supplementation.
In addition, they will receive Saccharomyces boulardii supplementation from admission to discharge.
|
|
有源比较器：Standard treatment includes fluid replacement and zinc supplementation.
Treatment should follow standard protocols with fluid replacement and zinc supplementation, but no additional Saccharomyces boulardii should be added until discharge.
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Children will be treated with standard methods involving fluid and zinc supplementation, without the use of any probiotics.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Duration of diarrhea
大体时间：Immediately after the intervention
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The cessation of acute diarrhea is determined when children met following criteria:
|
Immediately after the intervention
|
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The frequency of stool
大体时间：At day 1, 3, 5
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Total number of bowel movements per day
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At day 1, 3, 5
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Stool consistency assessed by Bristol stool chart
大体时间：At day 1, 3, 5
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The Bristol stool chart has 7 pictures of stool appearance.
The number 1 mean hard stool and number 7 mean watery stool.
|
At day 1, 3, 5
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Length of hospitalization
大体时间：Immediately after the intervention
|
The total length of hospitalization, measured in days
|
Immediately after the intervention
|
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Adverse events
大体时间：Immediately after the intervention
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The occurrence of adverse events during treatment, including such as rash and bloating.
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Immediately after the intervention
|
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Cost effectiveness
大体时间：Immediately after the intervention
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Total Cost per child from date of admission until discharge
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Immediately after the intervention
|
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Rate of Hospital readmission
大体时间：At day 14 and 28 after discharge from the hospital.
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The proportion of participants who were readmitted to the hospital after discharge
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At day 14 and 28 after discharge from the hospital.
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 学习椅：Thao Thi Phuong Nguyen, M.D、Can Tho University of Medicine and Pharmacy
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年8月31日
初级完成 (估计的)
2028年8月30日
研究完成 (估计的)
2028年8月30日
研究注册日期
首次提交
2026年8月31日
首先提交符合 QC 标准的
2026年9月8日
首次发布 (实际的)
2026年9月10日
研究记录更新
最后更新发布 (实际的)
2026年9月10日
上次提交的符合 QC 标准的更新
2026年9月8日
最后验证
2026年9月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.