NCT01735591

Administration of Probiotics in Cirrhotic Patients Listed for Liver Transplantation

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Medical University of Warsaw · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Liver Cirrhosis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Placebo	Placebo, 1 capsule a day from inclusion until the date of liver transplantation
DIETARY_SUPPLEMENT	Probiotic	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)

Timeline

• Start date: 2012-11-01
• Primary completion: 2015-11-01
• Completion: 2015-11-01
• First posted: 2012-11-28
• Last updated: 2016-07-29

Locations

1 site across 1 country: Poland