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Completed

NCT Number: NCT01735591

Administration of Probiotics in Cirrhotic Patients Listed for Liver Transplantation

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.

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Key information

Conditions

Liver Cirrhosis Digestive System Diseases Fibrosis Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of General, Transplant and Liver Surgery, Medical University of Warsaw

Warsaw, Masovian Voivodeship, 02-097, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Dietary Supplement

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

Probiotic

Dietary Supplement

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)

Primary outcomes

  1. All-cause postoperative mortality

    Time frame: 90 days after the date of liver transplantation

  2. Postoperative infection

    Time frame: 30 days from the date of liver transplantation

Secondary outcomes

  1. Mortality on the waiting list

    Time frame: From the date of inclusion until the date of liver transplantation

  2. Infections in the pre-transplantation period

    Time frame: From the date of inclusion until the date of transplantation

  3. Primary non-function after liver transplantation

    Time frame: 14 days after the date of liver transplantation

  4. Changes in model for end-stage liver disease score

    Time frame: From the date of inclusion until the date of transplantation

  5. Changes in Child-Turcotte-Pugh class

    Time frame: From the date of inclusion until the date of transplantation

  6. Number of hospital admissions due to infections in the pre-transplantation period

    Time frame: From the date of inclusion until the date of transplantation

  7. Number of hospital admission due to complications of liver cirrhosis in the pre-transplantation period

    Time frame: From the date of inclusion until the date of transplantation

  8. Serum activity of transaminases on the first 5 postoperative days

    Time frame: 5 days after the date of liver transplantation

  9. Serum bilirubin concentration in the first 5 postoperative days

    Time frame: 5 days after the date of liver transplantation

  10. International normalized ratio values during the first 5 postoperative days

    Time frame: 5 days after the date of liver transplantation

  11. Change in model for end-stage liver disease score in the pre-transplantation period

    Time frame: 10 weeks

    To be assessed if the period between inclusion in the study and liver transplantation would not be shorter than 10 weeks

  12. Change in Chil-Turcotte-Pugh class in the pre-transplantation period

    Time frame: 10 weeks

    To be assessed if the period between inclusion in the study and liver transplantation would not be shorter than 10 weeks

Other outcomes

  1. Changes in faecal microflora

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Medical University of Warsaw

Other

Collaborators

  • Ministry of Science and Higher Education, Poland

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Nov 28, 2012
Registry last updated
Jul 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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