Administration of Probiotics in Cirrhotic Patients Listed for Liver Transplantation

NCT01735591 | Completed DMC

• 1 other identifier: 1WB/3DG1
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Cirrhosis

Keywords

Liver cirrhosis; Liver transplantation; Probiotics; Mortality; Liver function; Infections

Outcome Measures

Primary Outcomes (2)

• All-cause postoperative mortality

  90 days after the date of liver transplantation

• Postoperative infection

  30 days from the date of liver transplantation

Secondary Outcomes (12)

• Mortality on the waiting list

  From the date of inclusion until the date of liver transplantation

• Infections in the pre-transplantation period

  From the date of inclusion until the date of transplantation

• Primary non-function after liver transplantation

  14 days after the date of liver transplantation

• Changes in model for end-stage liver disease score

  From the date of inclusion until the date of transplantation

• Changes in Child-Turcotte-Pugh class

  From the date of inclusion until the date of transplantation

Other Outcomes (1)

• Changes in faecal microflora

  10 weeks

Study Arms (2)

Probiotic

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Placebo DIETARY_SUPPLEMENT

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

Placebo

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)

Probiotic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Medical University of Warsaw: lead
• Ministry of Science and Higher Education, Poland: collaborator

Study Sites (1)

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

Warsaw, Masovian Voivodeship, 02-097, Poland

Location

Related Publications (4)

• 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.

  PMID: 37870148 DERIVED

• 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.

  PMID: 36126902 DERIVED

• 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.

  PMID: 33204004 DERIVED

• 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.

  PMID: 28506447 DERIVED

MeSH Terms

Conditions

Liver Cirrhosis; Infections

Interventions

Probiotics

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Michał Grąt, M.D.

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

  PRINCIPAL INVESTIGATOR

• Marek Krawczyk, Professor

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2012
• First Posted: November 28, 2012
• Study Start: November 1, 2012
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: July 29, 2016

Record last verified: 2015-11

Locations

PL (1)