Administration of Probiotics in Cirrhotic Patients Listed for Liver Transplantation

Medical University of Warsaw

Status: Completed

Conditions: Liver Cirrhosis

Treatments: Dietary Supplement: Probiotic; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01735591

1WB/3DG1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 55 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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55 participants in 2 patient groups, including a placebo group

Probiotic

Experimental group

Description:

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

Treatment:

Dietary Supplement: Probiotic

Placebo

Placebo Comparator group

Description:

Placebo, 1 capsule a day from inclusion until the date of liver transplantation

Treatment:

Dietary Supplement: Placebo