Efficacy and Safety of Saccharomyces Boulardii in Treatment of Acute Diarrhea in Children Aged 6 Months to 5 Years Old
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 206
- 试验地点
- 1
- 主要终点
- Duration of diarrhea
研究概览
简要总结
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.
详细描述
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
盲法说明
The blinding method was not performed.
入排标准
- 年龄范围
- 6 Months 至 60 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age from 6 months to 5 years old
- •Children are diagnosed with acute diarrhea according to WHO criteria.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Saccharomyces Boulardii Probiotic Supplement (Drug)
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.
干预措施: The child will be treated with standard method (Drug)
结局指标
主要结局
Duration of diarrhea
时间窗: Immediately after the intervention
The cessation of acute diarrhea is determined when children met following criteria: 1. Passing soft or formed stools twice in a row. 2. No bowel movements recorded for 12 consecutive hours. 3. Stool consistency returns to normal, corresponding to categories 3 to 5 on the Bristol stool scale.
The frequency of stool
时间窗: At day 1, 3, 5
Total number of bowel movements per day
Stool consistency assessed by Bristol stool chart
时间窗: At day 1, 3, 5
The Bristol stool chart has 7 pictures of stool appearance. The number 1 mean hard stool and number 7 mean watery stool.
次要结局
- Cost effectiveness(Immediately after the intervention)
- Length of hospitalization(Immediately after the intervention)
- Adverse events(Immediately after the intervention)
- Rate of Hospital readmission(At day 14 and 28 after discharge from the hospital.)
研究者
Nguyễn Thị Phương Thão
Principal Investigator
Can Tho University of Medicine and Pharmacy