Probiotics For The Prevention of Antibiotics Associated Diarrhea in the Pediatric Intensive Care Unit
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 主要终点
- Incidence of antibiotic associated diarrhea
研究概览
简要总结
The goal of this prospective trial is to learn about lactobacillus use in critically ill pediatric patients. The main question[s] it aims to answer are:
- Is lactobacillus GG effective in preventing antibiotic associated diarrhea in the PICU
- Is lactobacillus safe in critically ill pediatric patients Participants will be randomized to lactobacillus GG vs placebo while on antibiotics
If there is a comparison group: Researchers will compare lactobacillus GG to see if it prevents antibiotic associated diarrhea.
详细描述
The objective of this study was to assess the efficacy of lactobacillus GG (LGG) to prevent antibiotic-associated diarrhea (AAD) in the PICU.
Design:
Prospective randomized, double-blind, placebo-controlled trial
Setting:
15-20 bed PICU at University of South Alabama, Children's and Women's Hospital in Mobile, Alabama.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Matching placebo. Dispensed from pharmacy.
入排标准
- 年龄范围
- 1 Day 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Admitted to PICU
- •Requiring > 72 hrs of antibiotic therapy
- •< 17 years
- •Able to administer oral LGG or placebo
排除标准
- •Antibiotics 48 hours prior to hospital admission
- •Probiotic use within 7 days of admission
- •Pre-existing diarrhea at time of hospital admission or 24 hours prior to admission
- •Laxative therapy at time of admission or 48 hours prior to admission
- •HIV with CD4 < 250
- •Established immunologic deficiencies (ANC < 100)
- •Chronic steroid therapy ( > 10 days)
- •GI disorders including intussusception, lower bowel disease, bowel resection, irritable bowel syndrome, ulcerative colitis, or Crohn's disease
- •Status post-surgical patients with antibiotic prophylaxis (< 72 hours duration)
结局指标
主要结局
Incidence of antibiotic associated diarrhea
时间窗: Full time while on antibiotics and 48 hours after
Diarrhea was defined as stools \>200 mL or 200 g per day in patients over 10 kg and \> 20 mL/kg/day or \> 20 g/kg/day in patients \< 10 kg or 3 or more loose stools in 24 hours if the stools were not able to be weighed. When patients developed diarrhea lasting more than 72 hours, they were crossed over to the alternate treatment arm.
次要结局
- Tolerability of lactobacillus GG(2 weeks)
研究者
Allison Chung
Associate Professor
University of South Alabama