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Effect of Synbiotic on Postoperative Complications After Liver Transplantation

Primary Purpose

Liver Disease

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Synbiotic
Control
Sponsored by
Hospital de Clinicas de Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Liver Disease focused on measuring synbiotic, infections, probiotics, liver transplantation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All adults patients who are undergoing liver transplantation

Exclusion Criteria:

  • patients on parenteral nutrition

Sites / Locations

  • Hospital de Clínicas de Porto AlegreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Synbiotic

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Evaluate the effect of synbiotic on postoperative infection after liver transplantation
positive blood culture

Secondary Outcome Measures

Identify length of postoperative hospital stay
length of hospital stay will be counted in days
Identify duration of antibiotic therapy
The duration of antibiotic therapy will be counted in days
Identify mortality
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

Full Information

First Posted
October 7, 2016
Last Updated
October 17, 2016
Sponsor
Hospital de Clinicas de Porto Alegre
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1. Study Identification

Unique Protocol Identification Number
NCT02938871
Brief Title
Effect of Synbiotic on Postoperative Complications After Liver Transplantation
Official Title
Effect of Synbiotic on Postoperative Complications After Liver Transplantation - A Randomized Double-blind Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
March 2016 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
January 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital de Clinicas de Porto Alegre

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Disease
Keywords
synbiotic, infections, probiotics, liver transplantation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
76 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Synbiotic
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Synbiotic
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Control
Intervention Description
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.
Primary Outcome Measure Information:
Title
Evaluate the effect of synbiotic on postoperative infection after liver transplantation
Description
positive blood culture
Time Frame
15 days
Secondary Outcome Measure Information:
Title
Identify length of postoperative hospital stay
Description
length of hospital stay will be counted in days
Time Frame
up to 12 weeks
Title
Identify duration of antibiotic therapy
Description
The duration of antibiotic therapy will be counted in days
Time Frame
up to 30 days
Title
Identify mortality
Description
It will be considered mortality the events occurring up to 30 days after surgery
Time Frame
up to 30 days
Title
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
Time Frame
until one month before surgery and 10 days after surgery
Other Pre-specified Outcome Measures:
Title
Identify nutritional status of patients undergoing liver transplantation using the measurement of non-dominant handgrip and the measurement of adductor polices muscle
Time Frame
until one month before surgery and 10 days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All adults patients who are undergoing liver transplantation Exclusion Criteria: patients on parenteral nutrition
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cleber Kruel, doctor
Email
crkruel@hcpa.edu.br
First Name & Middle Initial & Last Name or Official Title & Degree
Nicole Bernardi, graduated
Email
nbernardi@hcpa.edu.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cleber Kruel, Doctor
Organizational Affiliation
Hospital de Clínicas de Porto Alegre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Clínicas de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande do Sul
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cleber Kruel, Doctor
Phone
+55 51 99129705
Email
crkruel@hcpa.edu.br
First Name & Middle Initial & Last Name & Degree
Nicole Bernardi
Phone
+55 51 95004590
Email
nbernardi@hcpa.edu.br

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
36126902
Citation
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.
Results Reference
derived

Learn more about this trial

Effect of Synbiotic on Postoperative Complications After Liver Transplantation

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