Administration of Probiotics in Cirrhotic Patients Listed for Liver Transplantation
- Conditions
- Liver Cirrhosis
- Registration Number
- NCT01735591
- Lead Sponsor
- Medical University of Warsaw
- Brief Summary
The aim of this study was to evaluate the impact of the administration of probiotics on outcomes of patients qualified for liver transplantation, both in the pre-transplant period and in the early postoperative period.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 55
- Liver cirrhosis
- Active status on the waiting list for liver transplantation
- Confirmed etiology of liver disease
- Malignancy
- Human Immunodeficiency Virus infection
- Immunosuppressive treatment prior to liver transplantation
- Cystic fibrosis
- Creatinine clearance rate < 50 mL/min
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Postoperative infection 30 days from the date of liver transplantation All-cause postoperative mortality 90 days after the date of liver transplantation
- Secondary Outcome Measures
Name Time Method Serum bilirubin concentration in the first 5 postoperative days 5 days after the date of liver transplantation Change in model for end-stage liver disease score in the pre-transplantation period 10 weeks To be assessed if the period between inclusion in the study and liver transplantation would not be shorter than 10 weeks
Changes in Child-Turcotte-Pugh class From the date of inclusion until the date of transplantation Number of hospital admissions due to infections in the pre-transplantation period From the date of inclusion until the date of transplantation Primary non-function after liver transplantation 14 days after the date of liver transplantation Changes in model for end-stage liver disease score From the date of inclusion until the date of transplantation Number of hospital admission due to complications of liver cirrhosis in the pre-transplantation period From the date of inclusion until the date of transplantation Mortality on the waiting list From the date of inclusion until the date of liver transplantation Infections in the pre-transplantation period From the date of inclusion until the date of transplantation Serum activity of transaminases on the first 5 postoperative days 5 days after the date of liver transplantation International normalized ratio values during the first 5 postoperative days 5 days after the date of liver transplantation Change in Chil-Turcotte-Pugh class in the pre-transplantation period 10 weeks To be assessed if the period between inclusion in the study and liver transplantation would not be shorter than 10 weeks
Trial Locations
- Locations (1)
Department of General, Transplant and Liver Surgery, Medical University of Warsaw
🇵🇱Warsaw, Mazowieckie, Poland
Department of General, Transplant and Liver Surgery, Medical University of Warsaw🇵🇱Warsaw, Mazowieckie, Poland