Drug Safety
Conditions
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)
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.
Interventions
OTHERProbiotics
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
OTHERcontrol
usual oral care
Sponsors
Mahidol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of subjects with pneumonia | up to 28 days | patient with pneumonia |
Countries
Thailand
Contacts
Primary ContactVisanu Thamlikitkul, MD
Outcome results
None listed