Administration of Probiotics in Cirrhotic Patients Listed for Liver Transplantation

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Ministry of Science and Higher Education, Poland
Information provided by (Responsible Party):
Medical University of Warsaw
ClinicalTrials.gov Identifier:
NCT01735591
First received: November 23, 2012
Last updated: November 27, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention
Liver Cirrhosis
Dietary Supplement: Placebo
Dietary Supplement: Probiotic

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: An Attempt to Optimize the Results of Liver Transplantation With Administration of Probiotics.

Resource links provided by NLM:


Further study details as provided by Medical University of Warsaw:

Primary Outcome Measures:
  • All-cause postoperative mortality [ Time Frame: 90 days after the date of liver transplantation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mortality on the waiting list [ Time Frame: From the date of inclusion until the date of liver transplantation ] [ Designated as safety issue: Yes ]
  • Postoperative infection [ Time Frame: 30 days from the date of liver transplantation ] [ Designated as safety issue: No ]
  • Infections in the pre-transplantation period [ Time Frame: From the date of inclusion until the date of transplantation ] [ Designated as safety issue: No ]
  • Primary non-function after liver transplantation [ Time Frame: 14 days after the date of liver transplantation ] [ Designated as safety issue: No ]
  • Changes in model for end-stage liver disease score [ Time Frame: From the date of inclusion until the date of transplantation ] [ Designated as safety issue: No ]
  • Changes in Child-Turcotte-Pugh class [ Time Frame: From the date of inclusion until the date of transplantation ] [ Designated as safety issue: No ]
  • Number of hospital admissions due to infections in the pre-transplantation period [ Time Frame: From the date of inclusion until the date of transplantation ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • Serum activity of transaminases on the first 5 postoperative days [ Time Frame: 5 days after the date of liver transplantation ] [ Designated as safety issue: No ]
  • Serum bilirubin concentration in the first 5 postoperative days [ Time Frame: 5 days after the date of liver transplantation ] [ Designated as safety issue: No ]
  • International normalized ratio values during the first 5 postoperative days [ Time Frame: 5 days after the date of liver transplantation ] [ Designated as safety issue: No ]
  • Change in model for end-stage liver disease score in the pre-transplantation period [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    To be assessed if the period between inclusion in the study and liver transplantation would not be shorter than 10 weeks


Other Outcome Measures:
  • Changes in faecal microflora [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 200
Study Start Date: November 2012
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Probiotic
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
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)
Placebo Comparator: Placebo
Placebo, 1 capsule a day from inclusion until the date of liver transplantation
Dietary Supplement: Placebo
Placebo, 1 capsule a day from inclusion until the date of liver transplantation

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01735591

Locations
Poland
Department of General, Transplant and Liver Surgery, Medical University of Warsaw
Warsaw, Mazowieckie, Poland, 02-097
Sponsors and Collaborators
Medical University of Warsaw
Ministry of Science and Higher Education, Poland
Investigators
Principal Investigator: Michał Grąt, M.D. Medical University of Warsaw, Department of General, Transplant and Liver Surgery
Study Chair: Marek Krawczyk, Professor Medical University of Warsaw, Department of General, Transplant and Liver Surgery
  More Information

No publications provided

Responsible Party: Medical University of Warsaw
ClinicalTrials.gov Identifier: NCT01735591     History of Changes
Other Study ID Numbers: 1WB/3DG1
Study First Received: November 23, 2012
Last Updated: November 27, 2012
Health Authority: Poland: Ministry of Science and Higher Education

Keywords provided by Medical University of Warsaw:
Liver cirrhosis
Liver transplantation
Probiotics
Mortality
Liver function
Infections

Additional relevant MeSH terms:
Liver Cirrhosis
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on October 23, 2014