Probiotics for Prevention of Ventilator-Associated Pneumonia (VAP)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- 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 |
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| Contact: Visanu Thamlikitkul, MD | 662-412-5994 | sivth@mahidol.ac.th |
| Thailand | |
| Siriraj Hospital | Recruiting |
| Bangkok, Thailand, 10700 | |
| Contact: Visanu Thamlikitkul, MD 662-412-5994 sivth@mahidol.ac.th | |
| Principal Investigator: Visanu Thamlikitkul, MD | |
| 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 Pneumonia, Ventilator-Associated Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections |
Cross Infection Infection Ventilator-Induced Lung Injury Lung Injury |
ClinicalTrials.gov processed this record on May 23, 2013