Effect of Synbiotic on Postoperative Complications After Liver Transplantation - A Randomized Double-blind Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Evaluate the effect of synbiotic on postoperative infection after liver transplantation
研究概览
简要总结
The purpose of this study is to evaluate the use of synbiotic in patients after liver transplantation and assess the effect of these agents on postoperative infections, antibiotic use, length of hospital stay, mortality and nutritional status.
详细描述
All patients who are undergoing liver transplantation at the Hospital de Clinicas de Porto Alegre over the next 18 months will be informed of the purpose of the study. The patients or their legal guardians provided will written an informed consent for participation at the study.
The patients will be allocated to the intervention or control groups by randomization in blocks. The intervention group will receive a synbiotic composition (Lactobacillus acidophilus NCFM SD5221 10bilhões; Lactobacillus rhamnosus HN001 5675 SD 10 billion; Lactobacillus paracasei LPC SD 5275 - 37 10 billion; Bifidobacterium lactis SD 5674 HN0019 10 billion; Fructooligosaccharide 5.5 g) and the control group will receive 6 g of maltodextrin.The patients will received a synbiotic composition or maltodextrin for 15 days, twice times a day, after liver transplantation, when the patients are able to start feeding.
Patients will be evaluated for the occurrence of infections, need for additional antibiotics, length of hospital stay and mortality.
The Nutritional assessment will be carried out before and after surgery. All information will be collected and stored prospectively and the clinical trial will follow the instructions of the Consolidated Standards of Reporting Trials - CONSORT 2010.
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
- Triple (Participant, Care Provider, Investigator)
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
- •All adults patients who are undergoing liver transplantation
排除标准
- •patients on parenteral nutrition
结局指标
主要结局
Evaluate the effect of synbiotic on postoperative infection after liver transplantation
时间窗: 15 days
positive blood culture
次要结局
- Identify length of postoperative hospital stay(up to 12 weeks)
- Identify mortality(up to 30 days)
- Identify nutritional status of patients undergoing liver transplantation using the questionnaire of subjective global assessment and the global nutritional assessment proposed by Royal Free Hospital(until one month before surgery and 10 days after surgery)
- Identify duration of antibiotic therapy(up to 30 days)