Probiotics for Prevention of Ventilator-Associated Pneumonia (VAP)

Mahidol University

Status and phase: Unknown; Phase 4

Conditions: Drug Safety

Treatments: Other: control; Other: Probiotics

Study type: Interventional

Funder types: Other

Identifiers

NCT01301131

SirirajCEU 54-002

Details and patient eligibility

About

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)

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Probiotic

Experimental group

Description:

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

Treatment:

Other: Probiotics

control

No Intervention group

Treatment:

Other: control