Drug SafetyPhase 4VAPNCT01301131
Probiotics for Prevention of Ventilator-Associated Pneumonia (VAP)
A Phase 4 study testing Probiotics in people with Drug Safety, run by Mahidol University at 1 site in Thailand.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Drug Safety
- What is being tested?
- Probiotics
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteThailand
- Study dates
- Dec 2011to Oct 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient age ≥ 18-year who received ventilator and agreed to participate by signing informed consent form
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Siriraj Hospital
Bangkok, Bangkok, 10700
Visanu Thamlikitkul, MD, 662-412-5994, sivth@mahidol.ac.th
Visanu Thamlikitkul, MD
About this study
Official title: Randomized Controlled Trial of Fermented Dairy Product Containing L. Casei Shirota for Prevention of Ventilator-Associated Pneumonia
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)
Read the 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.
- Conditions
- Drug Safety
- Being tested
- Probiotics, control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticsOther
Also called Yakult
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
controlOther
Also called regular care
usual oral care
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Experimental | 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 Receives: Other: Probiotics |
| control | No intervention | Not described Receives: Other: control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with pneumonia
patient with pneumonia
Measured: up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2011 (estimated)
- Study startDec 2011
- Primary completionAug 2013 (estimated)
- Study completionOct 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug SafetyStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Visanu Thamlikitkul, Mahidol University
- Investigators
- Visanu Thamlikitkul, MD, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01301131
- Sponsor's protocol ID
- SirirajCEU 54-002
- Acronym
- VAP
- Status last verified
- Dec 2011
- First submitted
- 18 Feb 2011
- Last updated
- 2 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Fermented Dairy Product Containing L. Casei Shirota for Prevention of Ventilator-Associated Pneumonia
- ClinicalTrials.gov ID
- NCT01301131
- Acronym / sponsor ID
- VAP / SirirajCEU 54-002
- Conditions
- Drug Safety
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Aug 2013 (estimated)
- Study completion
- Oct 2013 (estimated)
- First posted
- 23 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Experimental | Other: Probiotics80 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 |
| control | No intervention | Other: control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient age ≥ 18-year who received ventilator and agreed to participate by signing informed consent form
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProbioticsAlso: Yakult80 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 | Probiotic |
| controlAlso: regular careusual oral care | Other | control |
Primary outcome
Number of subjects with pneumonia
Time frame: up to 28 days
patient with pneumonia
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Visanu Thamlikitkul, MD principal investigator
Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Probiotics in people with Drug Safety, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Visanu Thamlikitkul, MD (662-412-5994, sivth@mahidol.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects with pneumonia (time frame: up to 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2012.