Probiotics for Prevention of Ventilator-Associated Pneumonia (VAP)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Mahidol University.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Visanu Thamlikitkul, Mahidol University
ClinicalTrials.gov Identifier:
NCT01301131
First received: February 18, 2011
Last updated: December 29, 2011
Last verified: December 2011

February 18, 2011
December 29, 2011
December 2011
August 2013   (final data collection date for primary outcome measure)
Number of subjects with pneumonia [ Time Frame: up to 28 days ] [ Designated as safety issue: Yes ]
patient with pneumonia
Same as current
Complete list of historical versions of study NCT01301131 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Probiotics for Prevention of Ventilator-Associated Pneumonia (VAP)
Randomized Controlled Trial of Fermented Dairy Product Containing L. Casei Shirota for Prevention of Ventilator-Associated Pneumonia

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)

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Drug Safety
  • 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
  • Other: control
    usual oral care
    Other Name: regular care
  • 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
    Intervention: Other: Probiotics
  • No Intervention: control
    Intervention: Other: control
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
October 2013
August 2013   (final data collection date for primary outcome measure)

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

Both
18 Years and older
No
Contact: Visanu Thamlikitkul, MD 662-412-5994 sivth@mahidol.ac.th
Thailand
 
NCT01301131
SirirajCEU 54-002
No
Visanu Thamlikitkul, Mahidol University
Mahidol University
Not Provided
Principal Investigator: Visanu Thamlikitkul, MD Mahidol University
Mahidol University
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP