Rapid Diagnostics and Probiotic Therapy for Paediatric Acute Gastroenteritis - a Randomized, Factorial, Controlled, Placebo-controlled, Pilot Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 76
- 试验地点
- 3
- 主要终点
- Height z-score (HAZ) adjusted for initial HAZ
研究概览
简要总结
Many children admitted to hospital in Botswana without bloody diarrhoea are presumed to have viral gastroenteritis and so not treated with antibiotics - but they may indeed have a treatable cause for their illness. We will conduct a randomized trial to see if rapid testing using novel methods to identify potentially treatable causes of diarrhoea leads to improved outcomes. We will also be randomizing children to probiotic therapy versus placebo (the standard of care) to see if this treatment decreases the duration of diarrhoea. The proposed study is a pilot trial, necessary before embarking on a large multi-centre trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Months 至 60 Months(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •acute non-bloody gastroenteritis
排除标准
- •diarrhoea > 14 days
- •sepsis, pneumonia, UTI, meningitis requiring empiric antibiotic therapy
- •malignancy, IBD
- •known link to another patient with diarrhoea of defined aetiology
- •transferred in already on antimicrobials
- •live outside study area
- •children with severe acute malnutrition will be eligible for diagnostic arm but not probiotic arm
研究组 & 干预措施
Rapid diagnostics and probiotic
干预措施: Rapid diagnostic (Other)
Rapid diagnostics and placebo
干预措施: Rapid diagnostic (Other)
Rapid diagnostics and placebo
干预措施: Placebo (Other)
Delayed diagnostics and placebo
干预措施: Placebo (Other)
Delayed diagnostics and probiotic
干预措施: Probiotic (Dietary Supplement)
Rapid diagnostics and probiotic
干预措施: Probiotic (Dietary Supplement)
结局指标
主要结局
Height z-score (HAZ) adjusted for initial HAZ
时间窗: 60 days post-enrollment
次要结局
- mortality(60 days post-enrollment)
- environmental enteropathy score(60 days post-enrollment)
- duration of diarrhoea(estimated average duration ~ 4 days.)
- Weight z-score (WAZ) adjusted for initial WAZ(60 days after enrolment)
研究者
Jeffrey Pernica
Head, Division of Pediatric Infectious Disease
Hamilton Health Sciences Corporation
