Clinical trial NCT01735591: Administration of Probiotics in Cirrhotic Patients Listed for Liver Transplantation
Official title: An Attempt to Optimize the Results of Liver Transplantation With Administration of Probiotics.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Cirrhosis
Keywords: Liver cirrhosis
Liver transplantation
Probiotics
Mortality
Liver function
Infections
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
Collaborators: name: Ministry of Science and Higher Education, Poland
First posted: 2012-11-28
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility 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

Primary outcomes:
measure: All-cause postoperative mortality
timeFrame: 90 days after the date of liver transplantation
measure: Postoperative infection
timeFrame: 30 days from the date of liver transplantation
Secondary outcomes:
measure: Mortality on the waiting list
timeFrame: From the date of inclusion until the date of liver transplantation
measure: Infections in the pre-transplantation period
timeFrame: From the date of inclusion until the date of transplantation
measure: Primary non-function after liver transplantation
timeFrame: 14 days after the date of liver transplantation
measure: Changes in model for end-stage liver disease score
timeFrame: From the date of inclusion until the date of transplantation
measure: Changes in Child-Turcotte-Pugh class
timeFrame: From the date of inclusion until the date of transplantation
measure: Number of hospital admissions due to infections in the pre-transplantation period
timeFrame: From the date of inclusion until the date of transplantation
measure: Number of hospital admission due to complications of liver cirrhosis in the pre-transplantation period
timeFrame: From the date of inclusion until the date of transplantation
measure: Serum activity of transaminases on the first 5 postoperative days
timeFrame: 5 days after the date of liver transplantation
measure: Serum bilirubin concentration in the first 5 postoperative days
timeFrame: 5 days after the date of liver transplantation
measure: International normalized ratio values during the first 5 postoperative days
timeFrame: 5 days after the date of liver transplantation
measure: Change in model for end-stage liver disease score in the pre-transplantation period
timeFrame: 10 weeks
measure: Change in Chil-Turcotte-Pugh class in the pre-transplantation period
timeFrame: 10 weeks
Other outcomes:
measure: Changes in faecal microflora
timeFrame: 10 weeks
Locations:
city: Warsaw
country: Poland
facility: Department of General, Transplant and Liver Surgery, Medical University of Warsaw
state: Mazowieckie
Study officials:
affiliation: Medical University of Warsaw, Department of General, Transplant and Liver Surgery
name: Michał Grąt, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University of Warsaw, Department of General, Transplant and Liver Surgery
name: Marek Krawczyk, Professor
role: STUDY_CHAIR
References:
citation: 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.
citation: Grat M, Grat K, Krawczyk M, Lewandowski Z, Krasnodebski M, Masior L, 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.
citation: 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.