Effectiveness of Lactobacillus Reuteri DSM 17938 in Preventing Nosocomial Diarrhea in Children: a Randomized, Double-blind Placebo Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 184
- 试验地点
- 2
- 主要终点
- Incidence of nosocomial diarrhea (defined as the passage of 3 or more loose or watery stools in a 24-hour period that will occur more than 72 hours after admission)
研究概览
简要总结
AIM: To determine the efficacy of Lactobacillus reuteri DSM 17938 at a dose of 10(9) CFU for the prevention of nosocomial diarrhea.
TRIAL DESIGN: Double-blind, placebo controlled RCT. INTERVENTION: L reuteri DSM 17938 in a daily dose of 10(9) CFU. PRIMARY OUTCOME: Nosocomial diarrhoea (3 or more loose or watery stools in a 24 h that will occur more than 72 h after admission).
详细描述
Nosocomial diarrhea is a common problem in hospitalized children. Previously, it has been documented that the administration of L reuteri DSM 17938 at a dose of 10(8) colony forming units (CFU) compared with placebo had no effect on the overall incidence of nosocomial diarrhea (Wanke & Szajewska, J Pediatr 2012). Whether higher doses of L reuteri DSM 17938 have such effects needs to be substantiated in further randomized trials.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Month 至 48 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 1-48 mo admitted to the hospital for reasons other than diarrhea
- •Signed informed consent.
排除标准
- •Acute gastroenteritis within 3 days before admission
- •Symptoms other than diarrhea suggesting gastroenteritis
- •Use of probiotics within 7 days before admission
- •Immunodeficiency disorders
- •Breastfeeding >50%
- •Underlying gastrointestinal tract disorder
- •Malnutrition (weight/high <3pc)
结局指标
主要结局
Incidence of nosocomial diarrhea (defined as the passage of 3 or more loose or watery stools in a 24-hour period that will occur more than 72 hours after admission)
时间窗: Any time starting 72 h after admission
次要结局
- Incidence of rotavirus diarrhea (ie, detection of rotavirus or antigen in the stools)(72 hours after admission to the hospital to 72 hours after discharge)
- Adverse effects(During hospitalisation (expected average 3-5 days) plus 72 h after discharge)
- Incidence of diarrhea- passage of 3 or more loose or watery stools in a 24-h period(from the time of admission to the time of discharge of the hospital-expected average 3-5 days)
- Duration of diarrhea (ie, time till the last loose or watery stool from the onset of diarrhea)(during hospitalisation (expected average 3-5 days) and 72 h after discharge)
- Need and the length of intravenous rehydration due to diarrhea(During the hospitalization-expected average 3-5 days)
- Prolongation of the hospitalization due to nosocomial diarrhea(during the hospitalization-expected average 3-5 days)
- Incidence of chronic diarrhea- lasting more than 14 days(untill 14 days after onset of diarrhea)
- Length of hospital stay(During hospitalisation-expected average 3-5 days)
研究者
Hanna Szajewska
Proffesor
Medical University of Warsaw