- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02928042
Inhibition Effects of Probiotics on Pathogens Associated With VAP
January 17, 2018 updated by: Feride Karacaer, Cukurova University
Inhibition Effects of Probiotics on Pathogens Associated With Ventilator Associated Pneumonia
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Ventilator associated pneumonia (VAP) is one of the most commonly seen hospital-acquired infections that occurs in patients who receive mechanical ventilation.
VAP usually occurs 48-72 hours after mechanical ventilation and is related increased incidence of multidrug-resistant infections, increased antibiotic use, extended mechanical ventilation time, increased patient stay in the intensive care unit (ICU), and increased patient stay in the hospital.
One recent intervention is the probiotic therapy which is a nonantibiotic strategy for maintenance of the host's aerodigestive microbial balance and VAP prevention.Common causative pathogens of VAP include Gram negative bacteria such as Pseudomonas aeruginosa, Klebsiella pneumoniae, and Acinetobacter species, and Gram-positive bacteria such as Staphylococcus aureus.
In this study, these Gram negative pathogens obtained from mechanical ventilated patients' tracheal aspiration culture and reference bacteria strains will be compared with Lactobacillus (LAB) members and nisin in the laboratory.
Probiotics' antimicrobial properties and effects on these bacteria's (obtained from patients and reference strains) growth rate will be investigated.
Study Type
Observational
Enrollment (Actual)
80
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Adana, Turkey, 01330
- Çukurova University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 78 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability 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.
Description
Inclusion Criteria:
- Patients who mechanically ventilated at least 48 hours in the intensive care unit
Exclusion Criteria:
- Patients who mechanically ventilated less than 48 hours
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Probiotics' antimicrobial properties and effects on P. aeruginosa, A. baumanii, Staph. auresu and K. pneumonia's growth rate.
Time Frame: 7 months
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7 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Dilek Özcengiz, Professor, Çukurova University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2016
Primary Completion (Actual)
January 1, 2018
Study Completion (Actual)
January 1, 2018
Study Registration Dates
First Submitted
October 6, 2016
First Submitted That Met QC Criteria
October 6, 2016
First Posted (Estimate)
October 7, 2016
Study Record Updates
Last Update Posted (Actual)
January 18, 2018
Last Update Submitted That Met QC Criteria
January 17, 2018
Last Verified
January 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PVAP69
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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