Administration of Probiotics in Cirrhotic Patients Listed for Liver Transplantation

Study Overview
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Brief Summary
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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
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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.

Official Title
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An Attempt to Optimize the Results of Liver Transplantation With Administration of Probiotics.

Conditions
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Liver Cirrhosis

Intervention / Treatment
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* Dietary Supplement: Placebo
* Dietary Supplement: Probiotic


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Liver cirrhosis Active status on the waiting list for liver transplantation Confirmed etiology of liver disease Exclusion Criteria: Malignancy Human Immunodeficiency Virus infection Immunosuppressive treatment prior to liver transplantation Cystic fibrosis Creatinine clearance rate < 50 mL/min

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotic<br>Capsules with 3x10^9 colony forming units (Lactococcus lactis PB 411 - 50%; Lactobacillus casei PB 121 - 25%; Lactobacillus acidophilus PB 111 - 12,5%; Bifidobacterium bifidum PB 211 - 12,5%). 1 capsule a day from inclusion until liver transplantation | Dietary Supplement: Probiotic<br>* Capsules with 3x10^9 colony forming units of: Lactococcus lactis PB 411 (50%), Lactobacillus casei PB 121 (25%), Lactobacillus acidophilus PB 111 (12,5%), Bifidobacterium bifidum PB 211 (12,5)<br>|
| Placebo Comparator: Placebo<br>Placebo, 1 capsule a day from inclusion until the date of liver transplantation | Dietary Supplement: Placebo<br>* Placebo, 1 capsule a day from inclusion until the date of liver transplantation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause postoperative mortality |  | 90 days after the date of liver transplantation | 
| Postoperative infection |  | 30 days from the date of liver transplantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Serum activity of transaminases on the first 5 postoperative days |  | 5 days after the date of liver transplantation | 
| Serum bilirubin concentration in 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 model for end-stage liver disease score in the pre-transplantation period | To be assessed if the period between inclusion in the study and liver transplantation would not be shorter than 10 weeks | 10 weeks | 
| Change in Chil-Turcotte-Pugh class in the pre-transplantation period | To be assessed if the period between inclusion in the study and liver transplantation would not be shorter than 10 weeks | 10 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Liver cirrhosis, Liver transplantation, Probiotics, Mortality, Liver function, Infections