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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00256087




Registration number
NCT00256087
Ethics application status
Date submitted
17/11/2005
Date registered
21/11/2005
Date last updated
20/11/2015

Titles & IDs
Public title
The Effect of Prophylactic Probiotic Lactobacilli in Enteral Feeding on Nosocomial Pneumonia Rates in Critically Ill Patients
Scientific title
The Effect of Prophylactic Probiotic Lactobacilli in Enteral Feeding on Nosocomial Pneumonia Rates in Critically Ill Patients
Secondary ID [1] 0 0
2004.067
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critical Illness 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Probiotic Lactobacillus
Other interventions - Lactose Powder

Placebo Comparator: Standard Care - Two capsules containing placebo will be given 12 hourly

Active Comparator: First active treatment - Two capsules containing probiotic lactobacillus fermentin given 12 hourly

Active Comparator: Second active reatment - Two capsules containing probiotic lactobacillus acidiphilus given 12 hourly


Treatment: Drugs: Probiotic Lactobacillus


Other interventions: Lactose Powder
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

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

Eligibility
Key inclusion criteria
1. Adult patients (18 years or over)admitted to ICU with an expected stay of more than 48
hours.

2. Patients who are commenced on enteral feeding via gastric or post pyloric routes.

3. Patients who consent or if the patients is incompetent, their next of kin who consent,
to inclusion in the study
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients less than 18 years old.

2. Patients who are already receiving probiotic treatment.

3. The lactobacillus acidophilus preparation to be used in the study, contains a very
small amount of MSG (total dose of 20mg/day, equivalent to 10% of the initial dose
used to test MSG sensitivity) and as a precaution, patients with asthma or recurrent
urticaria will be excluded.

4. Patients with HIV infection, pre-existing immunosuppression, or who are pregnant. As
the Lactobacillus is a live micro-organism, immunosuppressed and pregnant pateints
will be excluded.

5. Patients with a contra-indication to enteral feeding.

6. Patients with contra-indication to placement of enteral feeding tube.

7. Patients or next-of-kin who do not consent to inclusion in the study.

8. 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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2010
Sample size
Target
Accrual to date
Final
57
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Intensive Care Unit Royal Melbourne Hospital Grattan Street - Parkville
Recruitment postcode(s) [1] 0 0
3050 - Parkville

Funding & Sponsors
Primary sponsor type
Other
Name
Melbourne Health
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
To assess the effect of addition of probiotic Lactobacilli to standard enteral feeding on
infection rates and feeding efficacy in critically ill patients.

The study hypothesis is that critically ill patients who receive the addition of probiotic
lactobacilli to the enteral feed will lead to a reduced rate of hospital acquired infections.

The null hypothesis is that there will be no significant difference in the rate of hospital
acquired infection in critically ill patients who receive enteral feeding with or without the
addition of probiotic Lactobacilli.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00256087
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Megan Robertson
Address 0 0
Intensive Care Unit, Royal Melbourne Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00256087