CTRI/2008/091/000255未知Phase 3 4
"Efficacy and safety of Saccharomyces boulardii in acute childhood diarrhoea:adouble blinded randomised controlled trial ".
mohd mushir reyaz1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 待定
适应症
试验速览
- 阶段
- Phase 3 4
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- duration of diarrhoea
研究概览
简要总结
this is an ongoing double blinded randomized controlled clinical trial to see the efficacy and safety of Saccharomyces boulardii(250 mg BD for 3days or till recovery whichever is earlier) in acute childhood diarrhoea.it is being conducted at pediatric ward ,jnmc,amu,aligarh ,india.primary outcome variable is duration of diarrhoea .The secondary outcome variable are rehydration time,frequency of loose stool&vomiting,ORS consumed,adverse drug reaction to S.boulardii
研究设计
- 分配方式
- Stratified block randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
入选标准
- •children age 3mths-5yrs with acute diarrhoea.
排除标准
- •severe malnutrition ,systemic illness,encephalopathy,convulsion,feature of immunodeficiency,use of IV antibiotics.
结局指标
主要结局
duration of diarrhoea
时间窗: 3 consecutive semi-formed stool or no stool in last 12 hours
次要结局
- rehydration time ,ORS consumed,frequency of vomiting and diarrhoea,adverse drug reaction to S.boulardii(3 consecutive semiformed stool or no stool in last 12 hours)
研究者
研究点 (1)
Loading locations...
相似试验
Unknown
不适用
Efficacy and Safety of Probiotic Products for Digestive HealthHealthy AdultNCT06385639Wecare Probiotics Co., Ltd.60
已完成
2 期
Efficacy and Safety of Fuke Qianjin Capsule in Patients With Pelvic Inflammatory DiseasesPelvic Inflammatory DiseaseNCT04723069University of Karachi198
已完成
不适用
Effect of Bacillus Subtilis BS50 Supplementation on Gastrointestinal Symptoms in Healthy AdultsGastrointestinal HealthCardiovascular HealthImmune HealthDigestive HealthNCT05004454BIO-CAT Microbials, LLC76
进行中（未招募）
不适用
Investigation of the Effects of a Bifidobacterial Strain on Bowel Movement in Healthy AdultsInfrequent Bowel MovementsNCT06686420Morinaga Milk Industry Co., LTD80
已完成
不适用
Study Evaluating the Safety and TolerabilityHealthy VolunteersNCT04692506BioGaia AB36