NCT01301131

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)

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Dec 2011

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 18, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 23, 2011

Completed
9 months until next milestone

Study Start

First participant enrolled

December 1, 2011

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

January 2, 2012

Status Verified

December 1, 2011

Enrollment Period

1.7 years

First QC Date

February 18, 2011

Last Update Submit

December 29, 2011

Conditions

Drug Safety

Outcome Measures

Primary Outcomes (1)

  • Number of subjects with pneumonia

    patient with pneumonia

    up to 28 days

Study Arms (2)

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

Other: Probiotics

control

NO INTERVENTION
Other: control

Interventions

ProbioticsOTHER

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

Also known as: Yakult
Probiotic
controlOTHER

usual oral care

Also known as: regular care
control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient age ≥ 18-year who received ventilator and agreed to participate by signing informed consent form

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Siriraj Hospital

Bangkok, Bangkok, 10700, Thailand

RECRUITING

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Visanu Thamlikitkul, MD

    Mahidol University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Visanu Thamlikitkul, MD

CONTACT

662-412-5994sivth@mahidol.ac.th

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Faculty of Medicine Siriraj Hospital

Study Record Dates

First Submitted

February 18, 2011

First Posted

February 23, 2011

Study Start

December 1, 2011

Primary Completion

August 1, 2013

Study Completion

October 1, 2013

Last Updated

January 2, 2012

Record last verified: 2011-12

Locations

TH(1)