Effect of Synbiotic on Postoperative Complications After Liver Transplantation

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.

Study Overview

• Status: Unknown
• Conditions: Liver Disease
• Intervention / Treatment: Dietary supplement: Synbiotic; Dietary supplement: Control

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 Type: Interventional
• Enrollment (Anticipated): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil
      • Recruiting
      • Hospital De Clinicas De Porto Alegre
      • Contact: Cleber Kruel, Doctor; Phone Number: +55 51 99129705; Email: crkruel@hcpa.edu.br
      • Contact: Nicole Bernardi; Phone Number: +55 51 95004590; Email: nbernardi@hcpa.edu.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• All adults patients who are undergoing liver transplantation

Exclusion Criteria:

• patients on parenteral nutrition

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Dietary supplement: 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.
Placebo Comparator: 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.	Dietary supplement: 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Time Frame
Identify nutritional status of patients undergoing liver transplantation using the measurement of non-dominant handgrip and the measurement of adductor polices muscle	until one month before surgery and 10 days after surgery

Collaborators and Investigators

• Sponsor: Hospital de Clinicas de Porto Alegre
• Investigators: Principal Investigator: Cleber Kruel, Doctor, Hospital De Clinicas De Porto Alegre

Publications and helpful links

General Publications

• 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:CD014804. doi: 10.1002/14651858.CD014804.pub2. Review.

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): January 1, 2018

Study Registration Dates

• First Submitted: October 7, 2016
• First Submitted That Met QC Criteria: October 17, 2016
• First Posted (Estimate): October 19, 2016

Study Record Updates

• Last Update Posted (Estimate): October 19, 2016
• Last Update Submitted That Met QC Criteria: October 17, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: synbiotic; probiotics; infections; liver transplantation
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Postoperative Complications
• Other Study ID Numbers: 160012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No