Administration of Probiotics in Cirrhotic Patients Listed for Liver Transplantation

Liver Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01735591
• Other study ID #: 1WB/3DG1
• Status: Completed
• Phase: N/A
• First received: November 23, 2012
• Last updated: July 28, 2016
• Start date: November 2012
• Est. completion date: November 2015

Study information

• Verified date: November 2015
• Source: Medical University of Warsaw
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ministry of Science and Higher Education
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Fibrosis
• Liver Cirrhosis

Intervention

Dietary Supplement:
• Placebo
Placebo, 1 capsule a day from inclusion until the date of liver transplantation
• 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)

Locations

Country	Name	City	State
Poland	Department of General, Transplant and Liver Surgery, Medical University of Warsaw	Warsaw	Mazowieckie

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Warsaw	Ministry of Science and Higher Education, Poland

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in faecal microflora	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	10 weeks	No
Primary	All-cause postoperative mortality		90 days after the date of liver transplantation	No
Primary	Postoperative infection		30 days from the date of liver transplantation	No
Secondary	Mortality on the waiting list		From the date of inclusion until the date of liver transplantation	Yes
Secondary	Infections in the pre-transplantation period		From the date of inclusion until the date of transplantation	No
Secondary	Primary non-function after liver transplantation		14 days after the date of liver transplantation	No
Secondary	Changes in model for end-stage liver disease score		From the date of inclusion until the date of transplantation	No
Secondary	Changes in Child-Turcotte-Pugh class		From the date of inclusion until the date of transplantation	No
Secondary	Number of hospital admissions due to infections in the pre-transplantation period		From the date of inclusion until the date of transplantation	Yes
Secondary	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	No
Secondary	Serum activity of transaminases on the first 5 postoperative days		5 days after the date of liver transplantation	No
Secondary	Serum bilirubin concentration in the first 5 postoperative days		5 days after the date of liver transplantation	No
Secondary	International normalized ratio values during the first 5 postoperative days		5 days after the date of liver transplantation	No
Secondary	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	No
Secondary	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	No