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
  Purpose

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: February 18, 2011
Last Updated: December 29, 2011
Health Authority: Thailand: Ethical Committee

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

ClinicalTrials.gov processed this record on October 23, 2014