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| Name | Class |
|---|---|
| Ministry of Science and Higher Education, Poland | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Placebo | Placebo Comparator | Placebo, 1 capsule a day from inclusion until the date of liver transplantation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Dietary Supplement | Placebo, 1 capsule a day from inclusion until the date of liver transplantation |
|
| Measure | Description | Time Frame |
|---|---|---|
| All-cause postoperative mortality | 90 days after the date of liver transplantation | |
| Postoperative infection | 30 days from the date of liver transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in faecal microflora | 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of General, Transplant and Liver Surgery, Medical University of Warsaw | Warsaw | Masovian Voivodeship | 02-097 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37870148 | Derived | 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. | |
| 36126902 | 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. |
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| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| D007239 | Infections |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| 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) |
|
| 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 |
| Number of hospital admissions due to infections in the pre-transplantation period | 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 | From the date of inclusion until the date of transplantation |
| Serum activity of transaminases on the first 5 postoperative days | 5 days after the date of liver transplantation |
| Serum bilirubin concentration in the first 5 postoperative days | 5 days after the date of liver transplantation |
| International normalized ratio values during the first 5 postoperative days | 5 days after the date of liver transplantation |
| 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 | 10 weeks |
| 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 | 10 weeks |
| 33204004 | 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. |
| 28506447 | 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. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D019602 |
| Food and Beverages |