跳至主要内容
临床试验/NCT02025452
NCT02025452已完成4 期

Rapid Diagnostics and Probiotic Therapy for Paediatric Acute Gastroenteritis - a Randomized, Factorial, Controlled, Placebo-controlled, Pilot Trial

Jeffrey Pernica3 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2014年3月1日最近更新:
适应症
干预措施

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

Active Comparator

干预措施: Rapid diagnostic (Other)

Rapid diagnostics and placebo

Placebo Comparator

干预措施: Rapid diagnostic (Other)

Rapid diagnostics and placebo

Placebo Comparator

干预措施: Placebo (Other)

Delayed diagnostics and placebo

Placebo Comparator

干预措施: Placebo (Other)

Delayed diagnostics and probiotic

Experimental

干预措施: Probiotic (Dietary Supplement)

Rapid diagnostics and probiotic

Active Comparator

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

发起方
Jeffrey Pernica
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Jeffrey Pernica

Head, Division of Pediatric Infectious Disease

Hamilton Health Sciences Corporation

研究点 (3)

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