Clinical trial NCT02938871: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Liver Disease
Keywords: synbiotic
infections
probiotics
liver transplantation
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2016-10-19
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* All adults patients who are undergoing liver transplantation

Exclusion Criteria:

* patients on parenteral nutrition

Primary outcomes:
measure: Evaluate the effect of synbiotic on postoperative infection after liver transplantation
timeFrame: 15 days
Secondary outcomes:
measure: Identify length of postoperative hospital stay
timeFrame: up to 12 weeks
measure: Identify duration of antibiotic therapy
timeFrame: up to 30 days
measure: Identify mortality
timeFrame: up to 30 days
measure: 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
timeFrame: until one month before surgery and 10 days after surgery
Other outcomes:
measure: Identify nutritional status of patients undergoing liver transplantation using the measurement of non-dominant handgrip and the measurement of adductor polices muscle
timeFrame: until one month before surgery and 10 days after surgery
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: Rio Grande do Sul
Study officials:
affiliation: Hospital de Clínicas de Porto Alegre
name: Cleber Kruel, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
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.