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Effect of Synbiotic on Postoperative Complications After Liver Transplantation

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ClinicalTrials.gov Identifier: NCT02938871
Recruitment Status : Unknown
Verified October 2016 by Hospital de Clinicas de Porto Alegre.
Recruitment status was:  Recruiting
First Posted : October 19, 2016
Last Update Posted : October 19, 2016
Sponsor:
Information provided by (Responsible Party):
Hospital de Clinicas de Porto Alegre

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.

Condition or disease Intervention/treatment Phase
Liver Disease Dietary Supplement: Synbiotic Dietary Supplement: Control Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Effect of Synbiotic on Postoperative Complications After Liver Transplantation - A Randomized Double-blind Clinical Trial
Study Start Date : March 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Evaluate the effect of synbiotic on postoperative infection after liver transplantation [ Time Frame: 15 days ]
    positive blood culture


Secondary Outcome Measures :
  1. Identify length of postoperative hospital stay [ Time Frame: up to 12 weeks ]
    length of hospital stay will be counted in days

  2. Identify duration of antibiotic therapy [ Time Frame: up to 30 days ]
    The duration of antibiotic therapy will be counted in days

  3. Identify mortality [ Time Frame: up to 30 days ]
    It will be considered mortality the events occurring up to 30 days after surgery

  4. 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 Outcome Measures:
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All adults patients who are undergoing liver transplantation

Exclusion Criteria:

  • patients on parenteral nutrition

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02938871


Contacts
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Contact: Cleber Kruel, doctor crkruel@hcpa.edu.br
Contact: Nicole Bernardi, graduated nbernardi@hcpa.edu.br

Locations
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Brazil
Hospital de Clínicas de Porto Alegre Recruiting
Porto Alegre, Rio Grande do Sul, Brazil
Contact: Cleber Kruel, Doctor    +55 51 99129705    crkruel@hcpa.edu.br   
Contact: Nicole Bernardi    +55 51 95004590    nbernardi@hcpa.edu.br   
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
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Principal Investigator: Cleber Kruel, Doctor Hospital de Clínicas de Porto Alegre

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Responsible Party: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT02938871     History of Changes
Other Study ID Numbers: 160012
First Posted: October 19, 2016    Key Record Dates
Last Update Posted: October 19, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Hospital de Clinicas de Porto Alegre:
synbiotic
infections
probiotics
liver transplantation

Additional relevant MeSH terms:
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Liver Diseases
Postoperative Complications
Digestive System Diseases
Pathologic Processes