Administration of Probiotics in Cirrhotic Patients Listed for Liver Transplantation

• All-cause postoperative mortality [ Time Frame: 90 days after the date of liver transplantation ] [ Designated as safety issue: No ]
  

• Mortality on the waiting list [ Time Frame: From the date of inclusion until the date of liver transplantation ] [ Designated as safety issue: Yes ]
  
• Postoperative infection [ Time Frame: 30 days from the date of liver transplantation ] [ Designated as safety issue: No ]
  
• Infections in the pre-transplantation period [ Time Frame: From the date of inclusion until the date of transplantation ] [ Designated as safety issue: No ]
  
• Primary non-function after liver transplantation [ Time Frame: 14 days after the date of liver transplantation ] [ Designated as safety issue: No ]
  
• Changes in model for end-stage liver disease score [ Time Frame: From the date of inclusion until the date of transplantation ] [ Designated as safety issue: No ]
  
• Changes in Child-Turcotte-Pugh class [ Time Frame: From the date of inclusion until the date of transplantation ] [ Designated as safety issue: No ]
  
• Number of hospital admissions due to infections in the pre-transplantation period [ Time Frame: From the date of inclusion until the date of transplantation ] [ Designated as safety issue: Yes ]
  
• Number of hospital admission due to complications of liver cirrhosis in the pre-transplantation period [ Time Frame: From the date of inclusion until the date of transplantation ] [ Designated as safety issue: No ]
  
• Serum activity of transaminases on the first 5 postoperative days [ Time Frame: 5 days after the date of liver transplantation ] [ Designated as safety issue: No ]
  
• Serum bilirubin concentration in the first 5 postoperative days [ Time Frame: 5 days after the date of liver transplantation ] [ Designated as safety issue: No ]
  
• International normalized ratio values during the first 5 postoperative days [ Time Frame: 5 days after the date of liver transplantation ] [ Designated as safety issue: No ]
  
• Change in model for end-stage liver disease score in the pre-transplantation period [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
  To be assessed if the period between inclusion in the study and liver transplantation would not be shorter than 10 weeks
  
  
• Change in Chil-Turcotte-Pugh class in the pre-transplantation period [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
  To be assessed if the period between inclusion in the study and liver transplantation would not be shorter than 10 weeks
  
  

• Changes in faecal microflora [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
  Differences in the number of colony forming units in 1 g of stool for particular bacterial and fungal species after 10 weeks of probiotic/placebo administration
  
  

Gut microflora plays an important role in the pathogenesis of complications of liver cirrhosis, mainly due to microbial translocation. According to several studies, administration of probiotics in patients with cirrhosis has positive effect on minimal hepatic encephalopathy. The aim of this study was to evaluate the impact of probiotics administration on outcomes of patients qualified for liver transplantation, both in the pre-transplant period and in the early postoperative period. This study will be performed on 200 patients randomized into the probiotic and placebo groups. Daily administration of either probiotics or placebo will be continued from the date of inclusion in the study until the date of liver transplantation. A quantitative and qualitative analyses of faecal microflora will be performed in each patient before and after 10 week period (or shorter, depending on the time on the waiting list) of administration of either probiotic or placebo. Microbiological analyses of air samples from patients' home environment will be performed in each case. Both groups of patients will be compared with respect to primary and secondary outcome measures.