Lactobacillus Reuteri DSM 17938 in the Prevention of Antibiotic-associated Diarrhea in Children: Protocol of a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- frequencies of diarrhea and antibiotic associated diarrhea
研究概览
简要总结
The aim of this study is to assess the effect of Lactobacillus reuteri DSM 17938 administration for the prevention of diarrhea and AAD in children.
详细描述
Introduction
Addition of some probiotics appears to reduce the risk of antibiotic-associated diarrhea (AAD). Effects of probiotics are strain specific, thus the efficacy and safety of each probiotic strain should be established separately. We aim to assess the effect of Lactobacillus reuteri DSM 17938 administration for the prevention of diarrhea and AAD in children.
Methods and analysis:
A total of 250 children younger than 18 years treated with antibiotics will be enrolled into a double-blind, randomized placebo-controlled trial in which they will additionally receive L reuteri DSM 17938 at a dose 2 x 10^8 colony-forming units or an identically appearing placebo, orally, twice daily, for the entire duration of antibiotic treatment. The primary outcome measures will be the frequency of diarrhea and AAD. Diarrhea will be defined according to one of 3 definitions: (a) ≥3 loose or watery stools per day for a minimum of 48 hours during antibiotic treatment; (b) ≥3 loose or watery stools per day for a minimum of 24 hours during antibiotic treatment; (c) ≥2 loose or watery stools per day for a minimum of 24 hours during antibiotic treatment. AAD will be diagnosed in cases of diarrhea, defined clinically as above, caused by C. difficile or for otherwise unexplained diarrhea (i.e. negative laboratory stool tests for infectious agents).
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
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age younger than 18 years;
- •oral or intravenous antibiotic therapy which started within 24 hours of enrollment;
- •signed informed consent.
排除标准
- •pre-existing acute or chronic diarrhea,
- •history of chronic gastrointestinal disease (e.g., inflammatory bowel disease, cystic fibrosis, celiac disease, food allergy) or other severe chronic disease (e.g., neoplastic diseases), immunodeficiency,
- •use of probiotics within 2 weeks prior to enrollment,
- •use of antibiotics within 4 weeks prior to enrollment,
- •prematurity, and exclusive breastfeeding.
研究组 & 干预措施
L reuteri DSM 17938
L reuteri DSM 17938 2 x 10^8 twice daily
干预措施: Lactobacillus reuteri DSM 17938 (Drug)
Controls
Identically appearing placebo twice daily
干预措施: Placebo (Drug)
结局指标
主要结局
frequencies of diarrhea and antibiotic associated diarrhea
时间窗: during antibiotic treatment, an average of 10 days and 7 days of follow up
Three different definitions of diarrhea will be used, as the definitions of diarrhea/AAD in published studies vary. These will include diarrhea defined as: (a) ≥3 loose or watery stools per day for a minimum of 48 hours during antibiotic treatment; (b) ≥3 loose or watery stools per day for a minimum of 24 hours during antibiotic treatment, and (c) ≥2 loose or watery stools per day for a minimum of 24 hours during antibiotic treatment. AAD will be diagnosed in cases of diarrhea, defined clinically as above, caused by C. difficile or for otherwise unexplained diarrhea (i.e., negative laboratory stool tests for infectious agents). In all cases, loose or watery stools will correspond to scores of 5 to 7 on the BSF scale or A-consistency on the AISS.
次要结局
- the need for intravenous rehydration in any of the study groups(during antibiotic treatment, an average of 10 days and 7 days of follow up)
- infectious diarrhea(during antibiotic treatment, an average of 10 days and 7 days of follow up)
- the need for discontinuation of the antibiotic treatment(during antibiotic treatment, an average of 10 days)
- the need for hospitalization to manage the diarrhea (in outpatients)(during antibiotic treatment, an average of 10 days and 7 days of follow up)
- adverse events(during antibiotic treatment, an average of 10 days and 7 days of follow up)
研究者
Hanna Szajewska
Professor and Chair of Pediatrics at the Medical University of Warsaw
Medical University of Warsaw