The Treatment Effect of Bio-Three on Children With Enteritis Due to Salmonella or Rotavirus or Any Unknown Reason
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Quantitative Vesikari scales and qualitative severe diarrhea
研究概览
简要总结
Diarrhea due to acute enteritis is a common symptom in the children. Lots of patients are infected by rotavirus or salmonella.
Base on the past researches, there is benefit effect of probiotics on patients with diarrhea or acute enteritis. In this clinical study, bio-Three, a probiotic which contains three independent probiotics, will be used in patients with acute diarrhea.
This is a single site, controlled clinical research. About 80 patients will be enrolled into this study to evaluate the benefit effect of bio-Three among patients with acute enteritis due to rotavirus or salmonella or other unknown reason. Patients will be diagnosed and screened by inclusion and exclusion criteria and only eligible patients will be enrolled into this study.
详细描述
Intervention: Subjects were randomly assigned to receive control treatment (intravenous fluid, oral rice and half strength milk formula) or add-on treatment of the probiotics (Bio-three®) to the control treatment.
Main outcome measures: Quantitative Vesikari scales and qualitative severe diarrhea (Vesikari scale≥11) Exclusion criteria included immunodeficiency, severe abdominal distension with risk of bowel perforation, severe infection or sepsis, history of gastrointestinal tract surgery, and probiotics use in the preceding 1 week.
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 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical symptom of diarrhea less than 3 days
排除标准
- •Severe abdominal distension with risk of bowel perforation
- •Risk for sepsis
- •Past history with surgical operation of gastrointestinal tracts
- •immunodeficiency
- •probiotics use in the preceding 1 week
研究组 & 干预措施
Bio-Three
add-on treatment of the probiotics (Bio-three)
干预措施: Bio-three (Drug)
control treatment
control treatment (intravenous fluid, oral rice and half strength milk formula)
干预措施: Bio-three (Drug)
结局指标
主要结局
Quantitative Vesikari scales and qualitative severe diarrhea
时间窗: 7 days
Quantitative Vesikari scales and qualitative severe diarrhea (Vesikari scale≥11) Severity of diarrhea was evaluated according to the following features: volume of stools, fecal consistency, and frequency. Other clinical symptoms or signs, including fever, vomiting, daily intake, dehydration, and treatment were also assessed
次要结局
未报告次要终点
研究者
Yung-Feng Huang
Consultant Physician, Department of Pediatrics
Kaohsiung Veterans General Hospital.