Liver Cirrhosis
Conditions
Keywords
Liver cirrhosis, Liver transplantation, Probiotics, Mortality, Liver function, Infections
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.
Interventions
DIETARY_SUPPLEMENTPlacebo
Placebo, 1 capsule a day from inclusion until the date of liver transplantation
DIETARY_SUPPLEMENTProbiotic
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)
Sponsors
Ministry of Science and Higher Education, Poland
Medical University of Warsaw
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Postoperative infection | 30 days from the date of liver transplantation |
| All-cause postoperative mortality | 90 days after the date of liver transplantation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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 | 10 weeks | 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 | 10 weeks | To be assessed if the period between inclusion in the study and liver transplantation would not be shorter than 10 weeks |
| 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 | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Changes in faecal microflora | 10 weeks | 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 |
Countries
Poland
Outcome results
None listed