NCT00424905已完成4 期
Evaluation of the Effects of Enterogermina, 2 Billion Bacillus Clausii Spores, on the Intestinal Flora of Children Antibiotic Treated for Bacterial Upper Respiratory Tract Infections: Open, Pilot Study.
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Changes of microbial composition of fecal bacterial flora by PCR-DGGE analysis.
研究概览
简要总结
To assess the effects of Bacillus clausii (Enterogermina®) on fecal microbial flora (using Polymerase Chain Reaction - Denaturing Gradient Gel Electrophoresis - PCR-DGGE - Method) in antibiotic-treated children with complicated acute otitis media or beta-hemolytic streptococcal pharyngo-tonsillitis.
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
- None
入排标准
- 年龄范围
- 1 Year 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with persistency of symptoms and requiring antibiotics for bacterial upper respiratory tract infections, i.e. complicated acute otitis media (diagnosed by otoscopic examination) or beta-haemolytic streptococcal pharyngo-tonsillitis (diagnosed by pharyngeal swab and rapid antigen detection test or positive culture);
- •Outpatients or patients attending an emergency room for both diagnoses, and inpatients in case of complicated acute otitis media;
- •Written informed consent from both parents.
排除标准
- •History of clinically significant chronic diseases, or chronic diseases necessitating the use of continuous drug therapies, or of any disease that may interfere with the successful completion or the objectives of the trial;
- •Clinical evidence of relevant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurological or of any disease that may interfere with the successful completion or the objectives of the trial;
- •Use of antibiotics, prebiotics or probiotics (medications or dietetic supplements) in the last 2 weeks prior to study entry;
- •Hypersensitivity to the investigational product;
- •Subjects enrolled in another trial in the previous three months.
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
1
Experimental
Enterogermina® vials containing 2×109 spores of polyantibiotic resistant Bacillus clausii (test drug)
干预措施: Bacillus clausii (Drug)
结局指标
主要结局
Changes of microbial composition of fecal bacterial flora by PCR-DGGE analysis.
时间窗: between samples obtained at baseline and follow-up
次要结局
- Changes from baseline of body weight(During the total study period)
- Assessment of abdominal symptoms(Daily)
- Presence of Bacillus clausii spores in feces(after heat shock treatment on selective medium.)
- Number and rate of patients with GI symptoms and time to first development of symptoms.(recorded in a daily diary card for the total study period)
研究者
研究点 (1)
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