EUCTR2011-002343-99-GB进行中（未招募）1 期
An Open-label Study into the Efficacy and Dosing of Probiotic Escherichia coli Nissle 1917 for Prevention of Gram-negative Gastric Colonisation in Ventilated Intensive Care Patients. - Efficacy and dosing of probiotic E.coli in gastric colonisation(V1.0)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •We will recruit a total of 60 patients from the Heart of England NHS Foundation Trust critical care units, using a non-treatment group as the control. Patients =18 years that have been intubated for =24 hours and who are expected to require mechanical ventilation with a tracheal tube or tracheostomy for =48 hours will be considered for enrolment.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •The following exclusion criteria will apply: 1. Imminent treatment withdrawal 2. Designated consultee does not provide assent 3. Pregnancy or lactation 4. Therapy with immunosuppressants 5. Absolute neutrophil count =500/mm3 6. Gastrointestinal bleeding 7. Prosthetic cardiac valve or vascular graft 8. Cardiac trauma 9. History of rheumatic fever, endocarditis or congenital heart disease 10.Contraindication to enteral feeding 11.Gastro-oesophageal or intestinal injury or foregut surgery during the current admission 12.Acute pancreatitis 13.Participation in a CTIMP within the last 30 days
研究者
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