NCT02938871

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 7, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 19, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

October 19, 2016

Status Verified

October 1, 2016

Enrollment Period

1.8 years

First QC Date

October 7, 2016

Last Update Submit

October 17, 2016

Conditions

Liver Disease

Keywords

synbioticinfectionsprobioticsliver transplantation

Outcome Measures

Primary Outcomes (1)

  • Evaluate the effect of synbiotic on postoperative infection after liver transplantation

    positive blood culture

    15 days

Secondary Outcomes (4)

  • Identify length of postoperative hospital stay

    up to 12 weeks

  • Identify duration of antibiotic therapy

    up to 30 days

  • Identify mortality

    up to 30 days

  • 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

Other Outcomes (1)

  • 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

Study Arms (2)

Synbiotic

ACTIVE COMPARATOR

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

Control

PLACEBO COMPARATOR

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

Interventions

SynbioticDIETARY_SUPPLEMENT

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.

Synbiotic
ControlDIETARY_SUPPLEMENT

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.

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All adults patients who are undergoing liver transplantation

You may not qualify if:

  • patients on parenteral nutrition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

RECRUITING

Related Publications (1)

  • 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.

    PMID: 36126902DERIVED

MeSH Terms

Conditions

Liver DiseasesInfections

Interventions

Synbiotics

Condition Hierarchy (Ancestors)

Digestive System Diseases

Intervention Hierarchy (Ancestors)

PrebioticsDietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaProbioticsFood and Beverages

Study Officials

  • Cleber Kruel, Doctor

    Hospital de Clínicas de Porto Alegre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Cleber Kruel, doctor

CONTACT

crkruel@hcpa.edu.br

Nicole Bernardi, graduated

CONTACT

nbernardi@hcpa.edu.br

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2016

First Posted

October 19, 2016

Study Start

March 1, 2016

Primary Completion

December 1, 2017

Study Completion

January 1, 2018

Last Updated

October 19, 2016

Record last verified: 2016-10

Locations

BR(1)