Effect of Synbiotic on Postoperative Complications After Liver Transplantation

Liver Disease Clinical Trial

Official title:

Effect of Synbiotic on Postoperative Complications After Liver Transplantation - A Randomized Double-blind Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02938871
• Other study ID #: 160012
• Status: Recruiting
• Phase: N/A
• First received: October 7, 2016
• Last updated: October 17, 2016
• Start date: March 2016
• Est. completion date: January 2018

Study information

• Verified date: October 2016
• Source: Hospital de Clinicas de Porto Alegre
• Contact: Cleber Kruel, doctor
• Email: crkruel[@]hcpa.edu.br
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 76
• Est. completion date: January 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All adults patients who are undergoing liver transplantation

Exclusion Criteria:

• patients on parenteral nutrition

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Liver Disease
• Liver Diseases
• Postoperative Complications

Intervention

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.
• 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.

Locations

Country	Name	City	State
Brazil	Hospital de Clínicas de Porto Alegre	Porto Alegre	Rio Grande do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	Yes
Primary	Evaluate the effect of synbiotic on postoperative infection after liver transplantation	positive blood culture	15 days	Yes
Secondary	Identify length of postoperative hospital stay	length of hospital stay will be counted in days	up to 12 weeks	Yes
Secondary	Identify duration of antibiotic therapy	The duration of antibiotic therapy will be counted in days	up to 30 days	Yes
Secondary	Identify mortality	It will be considered mortality the events occurring up to 30 days after surgery	up to 30 days	Yes
Secondary	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	Yes