Effect of Synbiotic on Postoperative Complications After Liver Transplantation

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the use of synbiotic in patients after liver transplantation and assess the effect of these agents on postoperative infections, antibiotic use, length of hospital stay, mortality and nutritional status.

Detailed Description
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All patients who are undergoing liver transplantation at the Hospital de Clinicas de Porto Alegre over the next 18 months will be informed of the purpose of the study. The patients or their legal guardians provided will written an informed consent for participation at the study. The patients will be allocated to the intervention or control groups by randomization in blocks. The intervention group will receive a synbiotic composition (Lactobacillus acidophilus NCFM SD5221 10bilhões; Lactobacillus rhamnosus HN001 5675 SD 10 billion; Lactobacillus paracasei LPC SD 5275 - 37 10 billion; Bifidobacterium lactis SD 5674 HN0019 10 billion; Fructooligosaccharide 5.5 g) and the control group will receive 6 g of maltodextrin.The patients will received a synbiotic composition or maltodextrin for 15 days, twice times a day, after liver transplantation, when the patients are able to start feeding. Patients will be evaluated for the occurrence of infections, need for additional antibiotics, length of hospital stay and mortality. The Nutritional assessment will be carried out before and after surgery. All information will be collected and stored prospectively and the clinical trial will follow the instructions of the Consolidated Standards of Reporting Trials - CONSORT 2010.

Official Title
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Effect of Synbiotic on Postoperative Complications After Liver Transplantation - A Randomized Double-blind Clinical Trial

Conditions
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Liver Disease

Intervention / Treatment
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* Dietary Supplement: Synbiotic
* Dietary Supplement: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All adults patients who are undergoing liver transplantation Exclusion Criteria: patients on parenteral nutrition

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Synbiotic<br>The patients of this group will receive 6 grams of synbiotic composition, to be administered via feeding tube or orally, twice time a day, for 15 consecutive days. | Dietary Supplement: Synbiotic<br>* The patients of this group will receive 6 grams of synbiotic composition, to be administered via feeding tube or orally, twice time a day, for 15 consecutive days.<br>|
| Placebo Comparator: Control<br>The patients of this group will receive 6 grams of maltodextrin, to be administered via feeding tube or orally, twice time a day, for 15 consecutive days. | Dietary Supplement: Control<br>* The patients of this group will receive 6 grams of maltodextrin, to be administered via feeding tube or orally, twice time a day, for 15 consecutive days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the effect of synbiotic on postoperative infection after liver transplantation | positive blood culture | 15 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identify length of postoperative hospital stay | length of hospital stay will be counted in days | up to 12 weeks | 
| Identify duration of antibiotic therapy | The duration of antibiotic therapy will be counted in days | up to 30 days | 
| Identify mortality | It will be considered mortality the events occurring up to 30 days after surgery | up to 30 days | 
| Identify nutritional status of patients undergoing liver transplantation using the questionnaire of subjective global assessment and the global nutritional assessment proposed by Royal Free Hospital |  | until one month before surgery and 10 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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synbiotic, infections, probiotics, liver transplantation