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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2011 by Mahidol University.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Visanu Thamlikitkul, Mahidol University Identifier:
First received: February 18, 2011
Last updated: December 29, 2011
Last verified: December 2011
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 Intervention Phase
Drug Safety
Other: Probiotics
Other: control
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Randomized Controlled Trial of Fermented Dairy Product Containing L. Casei Shirota for Prevention of Ventilator-Associated Pneumonia

Resource links provided by NLM:

Further study details as provided by Mahidol University:

Primary Outcome Measures:
  • Number of subjects with pneumonia [ Time Frame: up to 28 days ] [ Designated as safety issue: Yes ]
    patient with pneumonia

Estimated Enrollment: 150
Study Start Date: December 2011
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

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

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

  Contacts and Locations
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Please refer to this study by its identifier: NCT01301131

Siriraj Hospital
Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
Principal Investigator: Visanu Thamlikitkul, MD Mahidol University
  More Information

Responsible Party: Visanu Thamlikitkul, Faculty of Medicine Siriraj Hospital, Mahidol University Identifier: NCT01301131     History of Changes
Other Study ID Numbers: SirirajCEU 54-002 
Study First Received: February 18, 2011
Last Updated: December 29, 2011
Health Authority: Thailand: Ethical Committee

Additional relevant MeSH terms:
Pneumonia, Ventilator-Associated
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Cross Infection
Ventilator-Induced Lung Injury
Lung Injury processed this record on January 17, 2017