Optimizing the Management of Pediatric Acute Diarrhoeal Disease in Botswana
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 276
- 试验地点
- 4
- 主要终点
- Height z-score (HAZ) adjusted for baseline 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. The investigators will conduct a randomized trial to see if rapid testing using novel methods to identify potentially treatable causes of diarrhoea leads to improved outcomes. The investigators will also be randomizing children to Lactobacillus reuteri DSM (daughter strain) 17938 therapy versus placebo (the standard of care) to see if this treatment decreases the duration of diarrhoea. The proposed study is a large multi-centre trial following the previous pilot 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 diarrhoeal illness (>= 3 stools in 24 hour period)
排除标准
- •diarrhoeal illness >=14 days
- •bloody stool
- •known inflammatory bowel disease, cystic fibrosis, or malignancy
- •live in a household with someone else documented to have a bacterial or parasitic enteric infection of defined aetiology
- •live outside catchment areas
- •no permanent address
- •no access to mobile phone
- •previous participation in this study
- •nosocomial diarrhoea
研究组 & 干预措施
Rapid diagnostics and probiotic
Participants randomized to this arm will have rapid enteric diagnostics performed on the day of enrolment. Those found to have a treatable pathogen will be prescribed antimicrobials that day. Participants will also be given Lactobacillus reuteri DSM 17938 5 x 10e8 cfu/mL x 60 days.
干预措施: Rapid diagnostics (Other)
Rapid diagnostics and probiotic
Participants randomized to this arm will have rapid enteric diagnostics performed on the day of enrolment. Those found to have a treatable pathogen will be prescribed antimicrobials that day. Participants will also be given Lactobacillus reuteri DSM 17938 5 x 10e8 cfu/mL x 60 days.
干预措施: Probiotic (Biological)
Rapid diagnostics and placebo
Participants randomized to this arm will have rapid enteric diagnostics performed on the day of enrolment. Those found to have a treatable pathogen will be prescribed antimicrobials that day. Participants will also be given placebo x 60 days.
干预措施: Rapid diagnostics (Other)
Rapid diagnostics and placebo
Participants randomized to this arm will have rapid enteric diagnostics performed on the day of enrolment. Those found to have a treatable pathogen will be prescribed antimicrobials that day. Participants will also be given placebo x 60 days.
干预措施: Placebo (Other)
No rapid diagnostics and probiotic
Participants randomized to this arm will have stool specimens processed after the conclusion of the study. Participants will also be given Lactobacillus reuteri DSM 17938 5 x 10e8 cfu/mL x 60 days.
干预措施: Probiotic (Biological)
No rapid diagnostics and placebo
Participants randomized to this arm will have stool specimens processed after the conclusion of the study. Participants will also be given placebo x 60 days.
干预措施: Placebo (Other)
结局指标
主要结局
Height z-score (HAZ) adjusted for baseline HAZ
时间窗: 60 days post-enrollment
次要结局
- Environmental enteropathy score (EES)(60 days)
- Diarrhoea recurrence(60 days after enrolment)
- Mortality(60 days post-enrollment)
- Weight z-score (WAZ) adjusted for baseline WAZ(60 days post-enrollment)
研究者
Jeffrey Pernica
Head, Division of Infectious Diseases
McMaster University