Efficacy of Lactobacillus GG With Diosmectite in Treatment Children With Acute Gastroenteritis: A Double Blind Randomized, Placebo- Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Duration of Diarrhea
研究概览
简要总结
Treatment diarrhea with Lactobacillus GG or smectite has proven efficacy. A randomized, double blind, placebo-control trial was performed to assess the effectiveness of both LGG and smectite in management of children with acute gastroenteritis (AGE).
详细描述
ESPGHAN agreed to use probiotics, with proven efficacy, and smectite in treatment of AGE as an adjunct to standard rehydration therapy. Among probiotics Lactobacillus GG were found to be beneficial in meta-analyses. Treatment with LGG was associated with a significant reduction in diarrhea duration.
A recent review systematically evaluated the efficacy of smectite in treating acute infections diarrhea in infants and children.
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 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children < 5 years old
- •diarrhea (defined as the passage of 3 or more loose or watery stools per day) for > 1 day but < 5 days
- •inform consent sing
排除标准
- •diarrhea < 1 or > 5 days,
- •a recent history of diarrhea indicated either by parents/guardian or hospital case notes,
- •underlying chronic gastrointestinal disease,
- •undernutrition (weight/height ratio below the 5th percentile),
- •systematic infection,
- •immune defects or immunosuppressive treatment
研究组 & 干预措施
Lactobacillus GG and Smectite
Children received:
- LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and
- smectite, dose 3 g, once daily orally until diarrhea stopped
干预措施: Smectite (Dietary Supplement)
Lactobacillus GG and Placebo
Children received:
- LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and
- placebo (glucose), dose 3 g, once daily orally until diarrhea stopped
干预措施: Placebo (Dietary Supplement)
Lactobacillus GG and Placebo
Children received:
- LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and
- placebo (glucose), dose 3 g, once daily orally until diarrhea stopped
干预措施: Lactobacillus GG (Dietary Supplement)
Lactobacillus GG and Smectite
Children received:
- LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and
- smectite, dose 3 g, once daily orally until diarrhea stopped
干预措施: Lactobacillus GG (Dietary Supplement)
结局指标
主要结局
Duration of Diarrhea
时间窗: counted in days during 7days
The primary outcome measure is duration of diarrhea (counted in days; from the first loose stool to the last one; end of diarrhea defined as last loose stool or at least 12hours without stool).
次要结局
- Frequency of Loose Stools,(number of loose stools during 7 days)
- Consistency of Stools(day 4-th)
- Need for Antibiotic Therapy,(yes/no, for 7days)
- Vomiting(how many times for 7days)
- Diarrhea Recurrence(7 days)
- Tolerance of Products(7days)
- Need for Hospitalization(7 days)
- Need for Intravenous Therapy(yes/no, for 7days)
- Duration of Intravenous Therapy(7days)
- Vomiting(yes/no, for 7days)