Liver Disease Clinical Trial
Official title:
Effect of Synbiotic on Postoperative Complications After Liver Transplantation - A Randomized Double-blind Clinical Trial
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
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