Impact of Emergency Department Probiotic (LGG) Treatment of Pediatric Gastroenteritis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 971
- 试验地点
- 10
- 主要终点
- Number of Participants With Modified Vesikari Scale Score >=9
研究概览
简要总结
The investigators will study the efficacy and side effect profile of LGG, a probiotic, in pediatric patients with acute gastroenteritis.
详细描述
Multicenter randomized controlled trial of LGG in patients 3-48 months of age presenting to the Emergency Department with acute gastroenteritis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Months 至 48 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 3-48 months (have not yet reached their fourth birthday); AND
- •Presence of 3 or more watery stools within 24 hours of screening; AND
- •Duration of vomiting or diarrhea less than 7 days; AND
- •Symptoms consistent with acute intestinal infectious process.
排除标准
- •Presence of an indwelling vascular access line; OR
- •Presence of structural heart disease excluding non-pathological heart murmurs; OR
- •Receiving immunosuppressive therapy or history of immunodeficiency; OR
- •Hematochezia in the preceding 48 hours; OR
- •Chronic gastrointestinal problems (e.g. short gut syndrome, inflammatory bowel disease); OR
- •Patients with known pancreatitis; OR
- •History of abdominal surgery; OR
- •Critically ill patients; OR
- •Family member with an indwelling vascular access line, or on immunosuppressive therapy, or with a known immunodeficiency; OR
- •Bilious emesis; OR
- •Probiotic use (supplement) in the preceding 2 weeks; OR
- •Oral or intravenous steroid use in the preceding six months; OR
- •Previously enrolled in this trial; OR
- •Allergy to lactobacillus or Microcrystalline Cellulose (MCC); OR
- •Allergy to erythromycin, clindamycin, AND betalactam antibiotics (all); OR
- •Not available for daily follow-up while symptomatic; OR
- •Parent/guardian not speaking English or Spanish; OR
- •Under 6 months old AND premature (<37 weeks).
研究组 & 干预措施
LGG
LGG 10^10 cfu PO bid x 5 days
干预措施: LGG (Drug)
Placebo
micro-crystalline cellulose PO bid x 5 days
干预措施: micro-crystalline cellulose (Drug)
结局指标
主要结局
Number of Participants With Modified Vesikari Scale Score >=9
时间窗: 14 days
This is a validated gastroenteritis severity score that includes duration and frequency of diarrhea, duration and frequency of vomiting, duration and frequency of fever and use of health care resources. Scores \>=9 indicate moderate-severe gastroenteritis. Higher is worse.
次要结局
- Number of Participants With LGG Bacteremia(1 month)
- Diarrhea Duration(14 days)