Effect of Probiotic Administration on Infection Incidence Rate in Living Donor Liver Transplantation Recipients
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- infection and mortality rates
研究概览
简要总结
A prospective, randomized, controlled study of the safety and efficacy of using Bacillus clausii probiotic oral preparation to decrease the incidence of infection during the first 30 days after living donor liver transplantation surgery.
详细描述
Patients planned for living donor liver transplantation would be randomized to either intervention or control group 2 weeks before surgery. Intervention group shall receive Bacillus clausii probiotics for 2 weeks. patients in both groups would be followed-up for adverse events and signs and symptoms of infection up to 30 days postoperatively.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 - 65 years.
- •Patients suffering from end stage liver disease (ESLD) with any etiology listed on waiting list and accepting to volunteer in the study with the informed consent.
- •Patients not suffering from any active infection at the start of the study.
排除标准
- •Patients with poorly controlled autoimmune disease on immunosuppression before transplantation.
- •Patients who undergo combined kidney-liver transplantation.
- •Patients with severe renal insufficiency (creatinine clearance <50 ml/min).
- •Patients with intestinal obstruction (ileus).
- •Patients with cerebral disorders with danger of aspiration.
- •Patients with roux en Y-anastomosis.
- •Patients with cystic fibrosis.
- •Retransplantation.
结局指标
主要结局
infection and mortality rates
时间窗: up to 30 days post-operatively
the occurrence of post-operative bacterial infection and mortality
次要结局
- Incidence of Probiotic related adverse events(starting 2 weeks before surgery and up to 30 days post-operatively)
- type of isolated bacteria(up to 30 days post-operatively)
- total hospital stay(up to 30 days post-operatively)
- Duration of antibiotic therapy(up to 30 days post-operatively)
- total ICU stay(up to 30 days post-operatively)
- quality of life assessment(at baseline, on day 15 before surgery, and at 30 days post-transplantation)
- Aspartate aminotransferase level (AST)(at baseline before probiotic administration and at 30 days post-transplantation)
- international normalized ratio(at baseline before probiotic administration and at 30 days post-transplantation)
- Total bilirubin level(at baseline before probiotic administration and at 30 days post-transplantation)
- Alanine aminotransferase level (ALT)(at baseline before probiotic administration and at 30 days post-transplantation)
研究者
Dina Ezzeldin Nabet
Principal investigator
Ain Shams University