NCT01940913已完成2 期
Efficacy and Safety of a Probiotic Product in Children With Antibiotic-associated Gastrointestinal Disorders.
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Probi AB
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Reduction of the incidence of loose/watery stools following antibiotic treatment in children.
研究概览
简要总结
To assess the tolerability and effect of a probiotic product, when co-administered with antibiotics, on the incidence and duration of loose/watery stools following the antibiotic treatment in children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children at the age of 1-11 years that have been ordinated to start antibiotic treatment except for penicillin.
- •Possibility to initiate the probiotic treatment within 24 hours after the first dose of the antibiotic treatment.
- •Children whose parents or legal caregivers have signed the informed consent to participate in the study.
排除标准
- •Chronic intestinal disease.
- •Current immunodeficiency or immunosuppressive treatment.
- •Chronic or acute diarrhoeal disease.
- •Use of laxatives the week before inclusion in the study.
- •Antibiotic treatment for the last four weeks before inclusion in the study.
- •Known hypersensitivity to any of the ingredients in the probiotic product or the placebo [potato starch, silicon dioxide, capsule (hypromellose, water) ± bacterial culture].
- •Intake of any probiotic products for the last two weeks before inclusion in the study.
- •Patient requiring hospitalisation. Lack of parents´/legal guardians´ informed consent.
研究组 & 干预措施
Probiotics
Active Comparator
干预措施: Probiotic capsules (Dietary Supplement)
Placebo
Placebo Comparator
干预措施: Placebo capsules (Dietary Supplement)
结局指标
主要结局
Reduction of the incidence of loose/watery stools following antibiotic treatment in children.
时间窗: 19-24 days
次要结局
未报告次要终点
研究者
研究点 (1)
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