- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01735591
Administration of Probiotics in Cirrhotic Patients Listed for Liver Transplantation
July 28, 2016 updated by: Medical University of Warsaw
An Attempt to Optimize the Results of Liver Transplantation With Administration of Probiotics.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
55
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Mazowieckie
-
Warsaw, Mazowieckie, Poland, 02-097
- Department of General, Transplant and Liver Surgery, Medical University of Warsaw
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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
|
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
|
Placebo, 1 capsule a day from inclusion until the date of liver transplantation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
All-cause postoperative mortality
Time Frame: 90 days after the date of liver transplantation
|
90 days after the date of liver transplantation
|
Postoperative infection
Time Frame: 30 days from the date of liver transplantation
|
30 days from the date of liver transplantation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mortality on the waiting list
Time Frame: From the date of inclusion until the date of liver transplantation
|
From the date of inclusion until the date of liver transplantation
|
|
Infections in the pre-transplantation period
Time Frame: From the date of inclusion until the date of transplantation
|
From the date of inclusion until the date of transplantation
|
|
Primary non-function after liver transplantation
Time Frame: 14 days after the date of liver transplantation
|
14 days after the date of liver transplantation
|
|
Changes in model for end-stage liver disease score
Time Frame: From the date of inclusion until the date of transplantation
|
From the date of inclusion until the date of transplantation
|
|
Changes in Child-Turcotte-Pugh class
Time Frame: From the date of inclusion until the date of transplantation
|
From the date of inclusion until the date of transplantation
|
|
Number of hospital admissions due to infections in the pre-transplantation period
Time Frame: From the date of inclusion until the date of transplantation
|
From the date of inclusion until the date of transplantation
|
|
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
|
From the date of inclusion until the date of transplantation
|
|
Serum activity of transaminases on the first 5 postoperative days
Time Frame: 5 days after the date of liver transplantation
|
5 days after the date of liver transplantation
|
|
Serum bilirubin concentration in the first 5 postoperative days
Time Frame: 5 days after the date of liver transplantation
|
5 days after the date of liver transplantation
|
|
International normalized ratio values during the first 5 postoperative days
Time Frame: 5 days after the date of liver transplantation
|
5 days after the date of liver transplantation
|
|
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
|
10 weeks
|
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
|
10 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
10 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Cooper TE, Scholes-Robertson N, Craig JC, Hawley CM, Howell M, Johnson DW, Teixeira-Pinto A, Jaure A, Wong G. Synbiotics, prebiotics and probiotics for solid organ transplant recipients. Cochrane Database Syst Rev. 2022 Sep 20;9(9):CD014804. doi: 10.1002/14651858.CD014804.pub2.
- Grąt M, Grąt K, Krawczyk M, Lewandowski Z, Krasnodębski M, Masior Ł, Patkowski W, Zieniewicz K. Post-hoc analysis of a randomized controlled trial on the impact of pre-transplant use of probiotics on outcomes after liver transplantation. Sci Rep. 2020 Nov 17;10(1):19944. doi: 10.1038/s41598-020-76994-3.
- Grat M, Wronka KM, Lewandowski Z, Grat K, Krasnodebski M, Stypulkowski J, Holowko W, Masior L, Kosinska I, Wasilewicz M, Raszeja-Wyszomirska J, Rejowski S, Bik E, Patkowski W, Krawczyk M. Effects of continuous use of probiotics before liver transplantation: A randomized, double-blind, placebo-controlled trial. Clin Nutr. 2017 Dec;36(6):1530-1539. doi: 10.1016/j.clnu.2017.04.021. Epub 2017 May 4.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2012
Primary Completion (Actual)
November 1, 2015
Study Completion (Actual)
November 1, 2015
Study Registration Dates
First Submitted
November 23, 2012
First Submitted That Met QC Criteria
November 27, 2012
First Posted (Estimate)
November 28, 2012
Study Record Updates
Last Update Posted (Estimate)
July 29, 2016
Last Update Submitted That Met QC Criteria
July 28, 2016
Last Verified
November 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1WB/3DG1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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