NCT00447161已完成4 期
Bacillus Clausii in Preventing Antibiotic-Associated Diarrhea Among Filipino Infant and Children: A Multi-Center, Randomized, Open-Label Controlled (Treatment vs No Treatment) Clinical Trial of Efficacy and Safety
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
- 323
- 试验地点
- 1
- 主要终点
- Reduction in the incidence of antibiotic-associated diarrhea (relative risk)
研究概览
简要总结
To determine the effectiveness of the pre-biotic Bacillus clausii in preventing antibiotic associated diarrhea among hospitalized immunocompetent Filipino children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically stable children with mild to moderate illness admitted for treatment of bacterial infection.
排除标准
- •Children with unstable medical condition
- •In any form of immunocompromized state
- •With contraindication to take medication
- •Has taken antibiotics for 3 weeks before start of trial.
- •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
Bacillus Clausii Multi ATB Resist
干预措施: Bacillus Clausii Multi ATB Resist (Drug)
2
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Reduction in the incidence of antibiotic-associated diarrhea (relative risk)
时间窗: From baseline to end of treatment
All adverse event regardless of seriousness or relationship to the study drug
时间窗: From baseline to end of treatment
次要结局
- Reduction in the number of antibiotic-associated diarrhea events per day(From baseline to end of treatment)
- Reduction in the severity of diarrhea events(From baseline to end of treatment)
- Reduction in Gastrointestinal-related symptoms (nausea, vomiting, abdominal pain)over-all reduction in the number of hospitalization days beween control and treatment groups.(From baseline to end of treatment)
- Reduction in C. dificille -associated diarrhea.(From baseline to end of treatment)
研究者
研究点 (1)
Loading locations...
相似试验
进行中（未招募）
不适用
Preventing Antibiotic-Associated Diarrhea Using ErcefloraDiarrhea associated to antibioticsMedDRA version: 17.1Level: LLTClassification code 10000706Term: Acute diarrheaSystem Organ Class: 100000004856EUCTR2014-004629-42-Outside-EU/EEASanofi323
已完成
不适用
Probiotics for the prevention of antibiotic-associated diarrhoea and Clostridium difficile associated diarrhoeaTopic: Oral and GastrointestinalSubtopic: Oral and Gastrointestinal (all Subtopics)Disease: GastrointestinalDigestive SystemDiarrhoeaISRCTN19604441Wrightington, Wigan and Leigh NHS Foundation Trust (UK)445
终止
不适用
Probiotics for Prevention of Antibiotic Associated Diarrhea and Clostridium Difficile Associated DiseaseDiarrheaNCT02076438Rutgers, The State University of New Jersey110
进行中（未招募）
不适用
Probiotics for the prevention of Antibiotics associated diarrhoea andClostridium difficile associated diarrhoeaA multi-centre, double-blind, randomized placebo controlled trialEUCTR2008-005244-16-GBWrightington, Wigan and Leigh NHS Trust
已完成
3 期
TEDDY: Spores of Bacillus Clausii in Acute Diarrhoea in ChildrenDiarrheaNCT00265369Sanofi420