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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02938871
Other study ID # 160012
Secondary ID
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


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
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