Effect of Synbiotic on Postoperative Complications After Liver Transplantation

Not Applicable

• Conditions: Liver Disease
• Interventions: Dietary Supplement: Control; Dietary Supplement: Synbiotic

• Registration Number: NCT02938871
• Lead Sponsor: Hospital de Clinicas de Porto Alegre

Brief Summary

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

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.

Study Timeline

• Study Start: 2016-03
• Status Verified: 2016-10
• Study First Submitted: 2016-10-07
• Study First Submitted QC: 2016-10-17
• Last Update Submitted: 2016-10-17
• Study First Posted: 2016-10-19
• Last Update Posted: 2016-10-19
• Primary Completion: 2017-12
• Study Completion: 2018-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 76

Inclusion Criteria

• All adults patients who are undergoing liver transplantation

Exclusion Criteria

• patients on parenteral nutrition

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Control	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.
Synbiotic	Synbiotic	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.

Primary Outcome Measures

Name	Time	Method
Evaluate the effect of synbiotic on postoperative infection after liver transplantation	15 days	positive blood culture

Secondary Outcome Measures

Name	Time	Method
Identify length of postoperative hospital stay	up to 12 weeks	length of hospital stay will be counted in days
Identify mortality	up to 30 days	It will be considered mortality the events occurring up to 30 days after surgery
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
Identify duration of antibiotic therapy	up to 30 days	The duration of antibiotic therapy will be counted in days

Trial Locations

Locations (1)

Hospital de Clínicas de Porto Alegre; 🇧🇷 Porto Alegre, Rio Grande do Sul, Brazil