EUCTR2006-002482-39-IT进行中（未招募）不适用
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. - DIAMANTE
SANOFI-AVENTIS OTC0 个研究点目标入组 50 人开始时间: 2007年1月10日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Children of either sex, aged 1 and 6 years; - 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.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- History of clinically significant chronic diseases, or chronic diseases necessitating the use of continuative 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 products; - Subjects and/or parents with unstable personality or not able to comply with the study procedures; - Subjects enrolled in another trial in the previous three months.
研究者
相似试验
进行中（未招募）
不适用
Efficacy evaluation of Enterogermina, 2 billion Bacillus clausii spores, on eradication of small intestinal bacterial overgrowth a randomised, parallel-group, open study - EFESOirritable bowel syndrome according to Rome II criteria and small intestinal bacterial overgrowthMedDRA version: 6.1Level: PTClassification code 10023003EUCTR2005-004934-42-ITSANOFI-AVENTIS OTC312
已完成
4 期
DIAMANTE - Diseases Infectious Analysis Microflora Antibiotic EffectGastrointestinal DiseasesNCT00424905Sanofi60
已完成
3 期
ENterogermina® (Bacillus Clausii) In the manaGeMent of diarrheA in ChildrenGastroenteritisNCT00457353Sanofi264
招募中
3 期
The effect of enteral administration of glutamine supplement for the prevention of ventilator associated pneumoniaVentilator associated pneumonia.Ventilator associated pneumoniaJ95.851IRCT20150221021159N5Esfahan University of Medical Sciences40
已完成
4 期
EFESO - EFficacy Enterogermina Small Intestinal Bacterial OvergrowthIrritable Bowel SyndromeNCT00331994Sanofi250