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Trial registered on ANZCTR


Registration number
ACTRN12605000543684
Ethics application status
Approved
Date submitted
9/09/2005
Date registered
28/09/2005
Date last updated
6/11/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of prophylactic probiotic lactobacilli in enteral feeding on nosocomiial pneumonia rates in critically ill patients.
Scientific title
The effect of prophylactic probiotic lactobacilli in enteral feeding on nosocomiial pneumonia rates in critically ill patients.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Nosocomial pneumonia rates in critically ill patients. 670 0
Condition category
Condition code
Respiratory 744 744 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients are randomised to one of three treatment groups, each comprising 100 patients:1. Standard therapy patients will receive enteral feeding (with fibre) aiming for the target rate determined by the treating clinician and the ICU dietician, as is current standard practice. Two capsules containing placebo will be given via the feeding tube twelve hourly as per active treatment group.2. The first active treatment group will receive enteral feeding (with fibre) plus probiotic Lactobacillus fermentumincluded in the feeding regimen. 2 capsules containing Lactobacilli fermentum (1011 organisms per capsule) will be delivered via the feeding tube twelve hourly. 3. The second active treatment group will receive enteral feeding (with fibre) plus probiotic Lactobacillus acidophilus included in the feeding regimen. 2 capsules containing Lactobacilli acidophilus (2 x 109 organisms per capsule) will be delivered via the feeding tube twelve hourly.Enteral feeding volume will aim for the target rate determined by the treating clinician and the ICU dietician, as is current standard practice. Patients will receive study lactobacillus/placebo until enteral feeding is ceased or for a maximum time period of 14 days.
Intervention code [1] 439 0
Prevention
Comparator / control treatment
Control group
Placebo

Outcomes
Primary outcome [1] 931 0
To determine if enteral feeds plus probiotic Lactobacilli are associated with a reduced rate of nosocomial pneumonia in critically ill patients during ICU stay.
Timepoint [1] 931 0
Secondary outcome [1] 1780 0
To determine the incidence of complications of enteral feeding with and without added probiotic Lactobacilli.
Timepoint [1] 1780 0
Secondary outcome [2] 1781 0
To assess if the efficacy of enteral feeding in critically ill patients during their ICU stay is improved by the addition of probiotic Lactobacilli.
Timepoint [2] 1781 0

Eligibility
Key inclusion criteria
1.Adult patient admitted to the ICU with an expected stay of more than 48 h.2.Patients who are to be commenced on enteral feeding via gastric or post-pyloric routes.3.Patients who consent or if the patient is incompetent, the next-of-kin who consent, to inclusion in the study.
Minimum age
18 Years
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1.Patients aged less than 18 years.2.Patients who are already receiving probiotic treatment.3.The Lactobacillus acidophilus preparation to be used in this study contains a very small amount of MSG (total dose 20 mg/day, equivalent to 10% of the initial dose used to test for MSG sensitivity) and as a precaution, patients with asthma or recurrent urticaria will be excluded.4.Patients with a known sensitivity to MSG will be excluded.5.Patients with HIV infection, pre-existing immunosuppression, or who are pregnant. As the Lactobacillus preparation contains live micro-organisms, immunosuppressed and pregnant patients will be excluded.6.Patients with a contra-indication to enteral feeding.7.Patients with a contra-indication to placement of an enteral feeding tube.8.Patients or next-of-kin who do not consent to inclusion in the study.9.Patients who are already enrolled in another study that may influence the outcome of the probiotic study.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sequentially numbered opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer generated randomisation matrix.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 825 0
Hospital
Name [1] 825 0
Intensive care departmental Funds, Royal Melbourne Hospital
Address [1] 825 0
Country [1] 825 0
Australia
Primary sponsor type
Hospital
Name
Intensive Care, Royal Melbourne Hospital
Address
Country
Australia
Secondary sponsor category [1] 693 0
None
Name [1] 693 0
Nil
Address [1] 693 0
Country [1] 693 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2091 0
Royal Melbourne Hospital
Ethics committee address [1] 2091 0
Ethics committee country [1] 2091 0
Australia
Date submitted for ethics approval [1] 2091 0
Approval date [1] 2091 0
Ethics approval number [1] 2091 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35490 0
Address 35490 0
Country 35490 0
Phone 35490 0
Fax 35490 0
Email 35490 0
Contact person for public queries
Name 9628 0
Prof cade
Address 9628 0
Intensive Care Unit
Royal Melbourne Hospital
Grattan Street
Parkville VIC 3050
Country 9628 0
Australia
Phone 9628 0
+61 3 93427710
Fax 9628 0
+61 3 93428812
Email 9628 0
jack.cade@mh.org.au
Contact person for scientific queries
Name 556 0
Belinda Howe
Address 556 0
Intensive Care Unit
Royal Melbourne
Grattan Street
Parkville VIC 3050
Country 556 0
Australia
Phone 556 0
+61 3 93427710
Fax 556 0
+61 3 93428812
Email 556 0
belinda.howe@mh.org.au

No information has been provided regarding IPD availability
Summary results
No Results