Efficacy and Safety of Probiotics in the Treatment of Acute Gastroenteritis in Children
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Biocodex
- 入组人数
- 317
- 试验地点
- 8
- 主要终点
- Time frame in hours up to the time of the last liquid or loose stool as recorded in the stool diary
研究概览
简要总结
- Primary Objective:
o To assess the efficacy of the probiotics in reducing the duration of diarrhea in children suffering from acute gastroenteritis.
-
Secondary Objectives:
-
To assess the efficacy of the probiotics in improving the frequency and consistency of stools.
-
To assess the efficacy of the probiotics in avoiding recurrence of diarrhea.
-
To assess the efficacy of the probiotics on the disease severity.
-
To assess the safety and tolerability of the studied probiotics.
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
- Single (Investigator)
盲法说明
Allocation-blinded study
入排标准
- 年龄范围
- 6 Months 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children of both gender aged between 6 months and 5 years
- •Presenting with acute diarrhea (3 or more loose or liquid stools in a 24-hour period) since at least the last 24h but less than 5 days
- •Signed informed consent of the legal representatives obtained before any study procedure
- •Parents able to fulfill in the stool diary according to the physician's opinion.
排除标准
- •Unable to take medication and fluids by mouth
- •More than 50% breastfeeding
- •Severe malnutrition, defined by a ratio weight/height at/or below -3SD
- •Severe dehydration, defined by a need of IV rehydration
- •Chronic underlying disease, including but not limited to severe gastrointestinal disorder, immunocompromised condition or systemic infection
- •Use of prohibited treatments
- •Contra-indications to the studied probiotics
研究组 & 干预措施
Saccharomyces boulardii
Floratil, 250 mg sachets, twice daily (1 in the morning and 1 in the evening) during 5 consecutive days.
干预措施: Probiotic : Saccharomyces boulardii (Biological)
Bacillus clausii
Enterogermina, 5 ml vials, twice daily (1 in the morning and 1 in the evening) during 5 consecutive days.
干预措施: Probiotic : Bacillus clausii (Biological)
结局指标
主要结局
Time frame in hours up to the time of the last liquid or loose stool as recorded in the stool diary
时间窗: 5 days
Time frame in hours up to the time of the last liquid or loose stoll (defined as type 6 or 7 on Bristol Stool Scale) followed by the first 24-hour period with stool consistency improvement (no liquid or loose stool), i.e. cessation of diarrhea as recorded by the parents in the stool diary.
次要结局
未报告次要终点