Probiotics for the Prevention of Antibiotics Associated Diarrhoea and Clostridium Difficile Associated Diarrhoea
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 231
- 试验地点
- 5
- 主要终点
- Development of antibiotic associated diarrhoea
研究概览
简要总结
The investigators aim to investigate whether the routine use of the probiotic formulation VSL#3 co-prescribed with antibiotics reduces the incidence of both Antibiotic associated diarrhoea and Clostridium Difficile associated diarrhoea.
详细描述
The investigators aim to find out whether VSL#3 can prevent Antibiotic associated diarrhoea and Clostridium Difficile associated diarrhoea when VSL#3 is giving during a course of systemic antibiotics. Patients will be randomized in a 1:1 proportion to receive either one sachet of VSL#3 or a similar looking placebo twice a day. This will be given for the length of the antibiotic course and another week thereafter. Follow-up will last until 28 days after the last antibiotic dose. Patient restarted on antibiotics during follow-up will be restarted on the trial medication and the 28 day follow-up will be recommenced.
This trial has 2 co-primary outcome measures.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 or older
- •Hospital inpatients
- •On systemic antibiotics for an infection
- •Antibiotics started within last 48 hours
排除标准
- •Diarrhoea at screening
- •Unable to take enteral meds
- •Patients on intensive care units
- •Severe Immunosuppression (neutropenia, AIDS, congenital immunoparesis, chemotherapy)
- •Risk of endocarditis (Artificial heart valves, history of rheumatic heart disease or infective endocarditis)
- •Regular consumption of probiotics until 1 week prior to admission
- •Acute severe pancreatitis Persistent vomiting (two days or more)
研究组 & 干预措施
VSL#3
Patients will receive one VSL #3 sachets twice a day for the duration of the antibiotic course and for one week after.
干预措施: VSL#3 (Drug)
Placebo
Patients will one placebo sachet twice a day for the duration of the antibiotic course and for one week after.
干预措施: Placebo (Drug)
结局指标
主要结局
Development of antibiotic associated diarrhoea
时间窗: 28 days post last antibiotic dose
Development of Clostridium difficile associated diarrhoea
时间窗: 28 days post last antibiotic dose
次要结局
- Length of Hospital Stay(28 days post last antibiotic dose)
- 30-day Mortality(30 days after initiation of therapy)
研究者
Christian Selinger
Coordinating investigator
National Health Service, United Kingdom