Bacillus Clausii Versus Multistrain Probiotics for Acute Watery Diarrhea in Children
Comparison of Effectiveness of Bacillus Clausii and Multistrain Probiotics (Lactobacillus Acidophilus, Lactobacillus Bulgaricus, Bifidobacterium, Streptococcus Thermophilus) in the Management of Children With Acute Watery Diarrhea: A Randomised Controlled Trial
研究概览
详细说明
Acute watery diarrhea is a major cause of morbidity among children worldwide, particularly in developing countries. Although oral rehydration solution (ORS) and zinc supplementation remain the cornerstone of treatment, probiotics are increasingly used as adjunctive therapy to reduce the duration and severity of illness.
Bacillus clausii and multistrain probiotic preparations have both demonstrated beneficial effects in children with acute diarrhea. However, evidence comparing their relative effectiveness is limited. This study aims to compare the effectiveness of Bacillus clausii (Enterogermina) and a multistrain probiotic preparation (Ecotec) containing Lactobacillus acidophilus, Lactobacillus bulgaricus, Bifidobacterium species, and Streptococcus thermophilus in the management of acute watery diarrhea in children.
This study is a randomized, open-label, parallel-group controlled trial conducted in the Department of Pediatric Medicine at The Children's Hospital and Institute of Child Health, Lahore. A total of 138 children aged 1-5 years with acute watery diarrhea will be enrolled and randomized in a 1:1 ratio into two treatment groups.
Participants in Group A will receive Bacillus clausii (Enterogermina) once daily for 5 days in addition to ORS and zinc supplementation. Participants in Group B will receive the multistrain probiotic preparation (Ecotec) once daily for 5 days in addition to ORS and zinc supplementation.
The primary outcome is duration of diarrhea. Secondary outcomes include stool frequency and stool consistency during the treatment period. The findings of this study may help identify the more effective probiotic strategy for the management of acute watery diarrhea in children and contribute to evidence-based pediatric practice.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Mamoona feroz
- 电话号码：+923315616443
- 邮箱：mamoona.feroz@yahoo.com
学习地点
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Punjab Province
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Lahore、Punjab Province、巴基斯坦、54000
- Children Hospital and Institute of Child Health, Lahore
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接触：
- Mamoona feroz
- 电话号码：+923315616443
- 邮箱：mamoona.feroz@yahoo.com
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-
参与标准
资格标准
适合学习的年龄
- 孩子
接受健康志愿者
描述
Inclusion Criteria:
- Patient with Acute watery diarrhea aged 1 year to 5 years.
- Both genders will be included.
- Patients whose guardians/ parents will give informed consent will participate in the study.
- Patients having mild to moderate dehydration will be included in study.
- Patients having mild to moderate malnutrition will be included in study.
Exclusion Criteria:
- Children having history of chronic diarrhea.
- Children having history of blood in stools.
- Children having cholera.
- Children with evidence of concurrent systemic infections other than acute diarrhea (e.g. respiratory tract infections, urinary tract infections, measles, meningitis etc).
- Children with known immunodeficiency disorders or undergoing immunosuppressive treatments (e.g., chemotherapy, corticosteroids).
- Children who have received antibiotics or zinc within the past 72 hours prior to enrollment, as this may interfere with gut flora and probiotic efficacy.
- Children who have received probiotics as a treatment for the current episode of diarrhea prior to study enrollment.
- Children with known allergies or hypersensitivity to probiotic components used in the study.
- Children who needed I/V antibiotics or I/V rehydration after enrollment.
学习计划
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 |
|---|---|
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有源比较器：Bacillus clausii Group
Participants will receive Bacillus clausii (Enterogermina) once daily for 5 days in addition to standard treatment with oral rehydration solution (ORS) and zinc supplementation.
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Bacillus clausii oral suspension containing 2 billion spores administered once daily for 5 days.
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有源比较器：Multistrain Probiotic Group
Participants will receive a multistrain probiotic preparation (Ecotec) once daily for 5 days in addition to standard treatment with oral rehydration solution (ORS) and zinc supplementation.
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Multistrain probiotic preparation containing Lactobacillus acidophilus, Lactobacillus bulgaricus, Bifidobacterium species, and Streptococcus thermophilus administered once daily for 5 days.
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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 |
|---|---|---|
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Duration of Diarrhea
大体时间：Up to 5 days after initiation of treatment
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The duration of acute diarrhea is determined by the timeframe (measured in days) spanning from the initial occurrence of abnormal (loose or liquid) stools to the subsequent return of normal stool consistency.
This assessment will consider both the frequency of daily stools and their consistency.
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Up to 5 days after initiation of treatment
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Daily Stool Frequency
大体时间：Daily for 5 days after initiation of treatment
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Number of stools passed per day during the treatment period.
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Daily for 5 days after initiation of treatment
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Stool Consistency
大体时间：Daily for 5 days after initiation of treatment
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Change in stool consistency assessed daily during the treatment period.
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Daily for 5 days after initiation of treatment
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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