NCT02928042

Brief Summary

This study evaluates that P. aeruginosa, A. baumannii, K. pneumonia and Staph aureus which are obtained from patients' tracheal aspiration culture who treated with mechanical ventilation will be compared with Lactobacillus (LAB) members and nisin bactriocin in the laboratory. The aim is to investigate the probiotics' antimicrobial properties and effects on these bacteria's growth rate.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2016

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

October 6, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 7, 2016

Completed
25 days until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

January 18, 2018

Status Verified

January 1, 2018

Enrollment Period

1.2 years

First QC Date

October 6, 2016

Last Update Submit

January 17, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Probiotics' antimicrobial properties and effects on P. aeruginosa, A. baumanii, Staph. auresu and K. pneumonia's growth rate.

    7 months

Study Arms (1)

Lactobacillus bacteria

Pseudomonas aeruginosa, Acinetobacter baumanii, Staph aureus and Klebsiella pneumoniae will be isolated from tracheal aspiration cultures. 80 isolates associated with pneumonia will be identified and made antibiogram with VITEK. Then antimicrobial effects of Lactobacillus bacteria (LAB) (Lc. lactis subsp. lactis (IL 1403), Lc. lactis subsp. lactis (ATCC 11454), Lactobacillus plantarum (FI8595), Leuconostoc mesenterodies subsp. cremoris (DSMZ 20346), Streptococcus thermophilus (NCFB2392), Pediococcus acidophilus (ATCC 25741)) and nisin bacteriocin will be investigated on the bacteria's growth rate in the laboratory.

Other: Lactobacillus bacteria

Interventions

Antimicrobial effects of Lactobacillus bacteria (LAB) and nisin bacteriocin on pathogen bacteria and commercial strains of the same bacteria's growth rate will be investigated.

Lactobacillus bacteria

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients who mechanically ventilated at least 48 hours will be included. Patients' tracheal aspirate cultures will be used for study. Pseudomonas aeruginosa, Acinetobacter baumanii, Staphylococcus aureus and Klebsiella pneumoniae will be isolated from tracheal aspiration cultures.Antimicrobial effects of Lactobacillus members will be investigated on the bacteria's growth rate in the laboratory.

You may qualify if:

  • Patients who mechanically ventilated at least 48 hours in the intensive care unit

You may not qualify if:

  • Patients who mechanically ventilated less than 48 hours

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cukurova University

Adana, 01330, Turkey (Türkiye)

Location

Related Publications (2)

  • Alexandre Y, Le Berre R, Barbier G, Le Blay G. Screening of Lactobacillus spp. for the prevention of Pseudomonas aeruginosa pulmonary infections. BMC Microbiol. 2014 Apr 27;14:107. doi: 10.1186/1471-2180-14-107.

    PMID: 24766663BACKGROUND
  • Petrof EO, Dhaliwal R, Manzanares W, Johnstone J, Cook D, Heyland DK. Probiotics in the critically ill: a systematic review of the randomized trial evidence. Crit Care Med. 2012 Dec;40(12):3290-302. doi: 10.1097/CCM.0b013e318260cc33.

    PMID: 22975886BACKGROUND

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Interventions

PrtB protein, bacteria

Condition Hierarchy (Ancestors)

Healthcare-Associated PneumoniaCross InfectionInfectionsPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Dilek Özcengiz, Professor

    Cukurova University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
7 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist doctor

Study Record Dates

First Submitted

October 6, 2016

First Posted

October 7, 2016

Study Start

November 1, 2016

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

January 18, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations