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

Primary Purpose

Drug Safety

Status

Unknown status

Phase

Phase 4

Locations

Thailand

Study Type

Interventional

Intervention

Probiotics

control

About this trial

This is an interventional prevention trial for Drug Safety

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Siriraj HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Probiotic

control

Arm 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

Outcomes

Primary Outcome Measures

Number of subjects with pneumonia

patient with pneumonia

Secondary Outcome Measures

Full Information

NCT ID

NCT01301131

First Posted

February 18, 2011

Last Updated

December 29, 2011

Sponsor

Mahidol University

1. Study Identification

Unique Protocol Identification Number

NCT01301131

Brief Title

Probiotics for Prevention of Ventilator-Associated Pneumonia (VAP)

Acronym

VAP

Official Title

Randomized Controlled Trial of Fermented Dairy Product Containing L. Casei Shirota for Prevention of Ventilator-Associated Pneumonia

Study Type

Interventional

2. Study Status

Record Verification Date

December 2011

Overall Recruitment Status

Unknown status

Study Start Date

December 2011 (undefined)

Primary Completion Date

August 2013 (Anticipated)

Study Completion Date

October 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mahidol University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Drug Safety

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Probiotic

Arm Type

Experimental

Arm 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

Arm Title

control

Arm Type

No Intervention

Intervention Type

Other

Intervention Name(s)

Probiotics

Other Intervention Name(s)

Yakult

Intervention 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

Intervention Type

Other

Intervention Name(s)

control

Other Intervention Name(s)

regular care

Intervention Description

usual oral care

Primary Outcome Measure Information:

Title

Number of subjects with pneumonia

Description

patient with pneumonia

Time Frame

up to 28 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Visanu Thamlikitkul, MD

Phone

662-412-5994

sivth@mahidol.ac.th

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Visanu Thamlikitkul, MD

Organizational Affiliation

Mahidol University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Siriraj Hospital

City

Bangkok

ZIP/Postal Code

10700

Country

Thailand

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Visanu Thamlikitkul, MD

Phone

662-412-5994

sivth@mahidol.ac.th

First Name & Middle Initial & Last Name & Degree

Visanu Thamlikitkul, MD

12. IPD Sharing Statement

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Probiotics for Prevention of Ventilator-Associated Pneumonia (VAP)

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