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Probiotics for Prevention of Ventilator-Associated Pneumonia (VAP) (VAP)

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ClinicalTrials.gov Identifier: NCT01301131
Recruitment Status : Unknown
Verified December 2011 by Visanu Thamlikitkul, Mahidol University.
Recruitment status was:  Recruiting
First Posted : February 23, 2011
Last Update Posted : January 2, 2012
Sponsor:
Information provided by (Responsible Party):
Visanu Thamlikitkul, Mahidol University

Brief Summary:
Hospitalized patients with ventilator are randomized to receive fermented dairy product containing L. casei shirota or nothing. The main outcome is development of ventilator-associated pneumonia (VAP)

Condition or disease Intervention/treatment Phase
Drug Safety Other: Probiotics Other: control Phase 4

Detailed Description:
Fermented dairy product containing L. casei shirota has bee shown to inhibit multi-drug-resistant bacteria. This study is conducted to determine if Fermented dairy product containing L. casei shirota can prevent ventilator-associated pneumonia.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Randomized Controlled Trial of Fermented Dairy Product Containing L. Casei Shirota for Prevention of Ventilator-Associated Pneumonia
Study Start Date : December 2011
Estimated Primary Completion Date : August 2013
Estimated Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Probiotic
80 ml of fermented dairy product containing L. casei shirota via nasogastric tube once daily and 80 ml of fermented dairy product containing L. casei shirota oral rinse once daily
Other: Probiotics
80 ml of fermented dairy product containing L. casei shirota via nasogastric tube once daily and 80 ml of fermented dairy product containing L. casei shirota oral rinse once daily
Other Name: Yakult
No Intervention: control Other: control
usual oral care
Other Name: regular care



Primary Outcome Measures :
  1. Number of subjects with pneumonia [ Time Frame: up to 28 days ]
    patient with pneumonia



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

Inclusion Criteria:

Patient age ≥ 18-year who received ventilator and agreed to participate by signing informed consent form

Exclusion Criteria:

Immunocompromised host (e.g. HIV infection, On immunosupressive agents, ANC ≤ 500 cell/ml), Pregnancy, History of congenital heart disease, rheumatic fever, previously infective endocarditis, prosthetic valve, Contraindication for enteral feeding, History of milk or milk-product allergy


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): NCT01301131


Contacts
Contact: Visanu Thamlikitkul, MD 662-412-5994 sivth@mahidol.ac.th

Locations
Thailand
Siriraj Hospital Recruiting
Bangkok, Thailand, 10700
Contact: Visanu Thamlikitkul, MD    662-412-5994    sivth@mahidol.ac.th   
Principal Investigator: Visanu Thamlikitkul, MD         
Sponsors and Collaborators
Mahidol University
Investigators
Principal Investigator: Visanu Thamlikitkul, MD Mahidol University

Responsible Party: Visanu Thamlikitkul, Faculty of Medicine Siriraj Hospital, Mahidol University
ClinicalTrials.gov Identifier: NCT01301131     History of Changes
Other Study ID Numbers: SirirajCEU 54-002
First Posted: February 23, 2011    Key Record Dates
Last Update Posted: January 2, 2012
Last Verified: December 2011

Additional relevant MeSH terms:
Pneumonia
Pneumonia, Ventilator-Associated
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Cross Infection
Infection
Ventilator-Induced Lung Injury
Lung Injury