Bacillus Particles Prevent More Children's Antibiotic-associated Diarrhea (AAD), Randomized, Double-blind, Controlled Clinical Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 480
- 主要终点
- Record daily stool frequency, shape observation excrement
研究概览
简要总结
This prospective, multicenter, randomized, double-blind, placebo-controlled clinical study, into the group of children in the hospital that use clinical antibiotics from one month to three years old，by observing the given antibiotics at the same time with the whole bowel raw or placebo, prevent the happening of the antibiotic associated diarrhea, evaluate the whole bowel prevention clinical efficacy and safety of AAD.
详细描述
This prospective, multicenter, randomized, double-blind, placebo-controlled clinical study, into the group of children in the hospital that use clinical antibiotics from one month to three years old，by observing the given antibiotics at the same time with the whole bowel raw or placebo, prevent the happening of the antibiotic associated diarrhea, evaluate the whole bowel prevention clinical efficacy and safety of AAD.
Outcome measures
- MAIN OUTCOME MEASURES: The incidence of diarrhea (stool frequency and character daily rates), the duration of diarrhea, the degree of diarrhea occur.
- Secondary outcomes: intestinal flora and relevant metabolites, micro-environmental changes.
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 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 1-3 years
- •no diarrhea-related symptoms
- •the diagnosis of lower respiratory tract infection (acute bronchitis, pneumonia) in hospitalized children
- •the need for penicillins, cephalosporin antibiotic treatment, treatment for 7-14 days, combined with other antimicrobial agents alone
- •parent or guardian signed informed consent (6）Not used in children with related traditional Chinese medicine injection
排除标准
- •diarrhea in the group, or 2 weeks before admission into children with diarrhea
- •children with ICU wards, digestive tract malformations, children with gastrointestinal surgery, congenital heart disease, artificial heart surgery, children with rheumatic heart disease, infective endocarditis
- •receiving immunosuppressive agents in children
- •Children who received any probiotic preparation 2 weeks before enrollment
研究组 & 干预措施
Bacillus licheniformis Intervention
The intervention is use Bacillus licheniformis particles，The drugs 1 bag each time, three times a day, for taking seven days; children observed during the test is no longer taking other probiotic preparations, and any other proprietary Chinese medicine preparation
干预措施: Bacillus licheniformis Intervention (Drug)
placebo Intervention
The intervention is use placebo，The drugs 1 bag each time, three times a day, for taking seven days; children observed during the test is no longer taking other probiotic preparations, and any other proprietary Chinese medicine preparation
干预措施: placebo Intervention (Other)
结局指标
主要结局
Record daily stool frequency, shape observation excrement
时间窗: every day，A total of seven days
Record daily stool frequency, excrement shape. According to Bristol who Chart of shape evaluation standard of excrement and urine, feces traits can be divided into seven grades, as picture shown in feces traits scale, record with feces corresponding score, score 5 or more, it indicates that the waste is not normal, diarrhea symptoms
次要结局
- Strain type(the first day and the seven day)