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Liver CirrhosisNCT01735591

Administration of Probiotics in Cirrhotic Patients Listed for Liver Transplantation

A study testing Probiotic in people with Liver Cirrhosis, run by Medical University of Warsaw at 1 site in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Liver Cirrhosis
What is being tested?
Probiotic
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
55 participants
Where
1 sitePoland
Study dates
Nov 2012to Nov 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Liver cirrhosis
  • Active status on the waiting list for liver transplantation
  • Confirmed etiology of liver disease

Who cannot join

  • Malignancy
  • Human Immunodeficiency Virus infection
  • Immunosuppressive treatment prior to liver transplantation
  • Cystic fibrosis
  • Creatinine clearance rate < 50 mL/min

Trial locations and contacts

1 site in 1 country.

Poland1 site

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

    Warsaw, Masovian Voivodeship, 02-097

Other trials in Poland

About this study

Official title: 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.

Read the 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.

Conditions
Liver Cirrhosis
Being tested
Placebo, Probiotic
Keywords
Liver cirrhosis, Liver transplantation, Probiotics, Mortality, Liver function, Infections
Medical subject headings
Liver Cirrhosis, Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDietary supplement

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

  • ProbioticDietary 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)

Study groups in NCT01735591
Study groupRoleWhat they receive
ProbioticExperimentalCapsules 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
Receives: Dietary Supplement: Probiotic
PlaceboPlacebo comparatorPlacebo, 1 capsule a day from inclusion until the date of liver transplantation
Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. All-cause postoperative mortality

    Measured: 90 days after the date of liver transplantation

  2. Postoperative infection

    Measured: 30 days from the date of liver transplantation

Secondary outcomes (12)

  1. Mortality on the waiting list

    Measured: From the date of inclusion until the date of liver transplantation

  2. Infections in the pre-transplantation period

    Measured: From the date of inclusion until the date of transplantation

  3. Primary non-function after liver transplantation

    Measured: 14 days after the date of liver transplantation

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

    Measured: From the date of inclusion until the date of transplantation

  5. Changes in Child-Turcotte-Pugh class

    Measured: From the date of inclusion until the date of transplantation

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

    Measured: 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

    Measured: From the date of inclusion until the date of transplantation

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

    Measured: 5 days after the date of liver transplantation

  9. Serum bilirubin concentration in the first 5 postoperative days

    Measured: 5 days after the date of liver transplantation

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

    Measured: 5 days after the date of liver transplantation

  11. 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

    Measured: 10 weeks

  12. 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

    Measured: 10 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Nov 2012 (estimated)
  2. Study startNov 2012
  3. Primary completionNov 2015
  4. Study completionNov 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01735591
Sponsor's protocol ID
1WB/3DG1
Status last verified
Nov 2015
First submitted
23 Nov 2012
Last updated
29 Jul 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • Cooper TE, Khalid R, Chan S, Craig JC, Hawley CM, Howell M, Johnson DW, Jaure A, Teixeira-Pinto A, Wong G. Synbiotics, prebiotics and probiotics for people with chronic kidney disease. Cochrane Database Syst Rev. 2023 Oct 23;10(10):CD013631. doi: 10.1002/14651858.CD013631.pub2.

    PubMed 37870148

  • 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.

    PubMed 36126902

  • 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.

    PubMed 33204004

  • 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.

    PubMed 28506447

Questions about this trial

What is this clinical trial studying?

A study testing Probiotic in people with Liver Cirrhosis, run by Medical University of Warsaw at 1 site in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All-cause postoperative mortality (time frame: 90 days after the date of liver transplantation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01735591, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2016.

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