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The Effect of Prophylactic Probiotic Lactobacilli in Enteral Feeding on Nosocomial Pneumonia Rates in Critically Ill Patients

Primary Purpose

Critical Illness

Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Probiotic Lactobacillus
Lactose Powder
Sponsored by
Melbourne Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Critical Illness focused on measuring Nosocomial rates in critically ill patients

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Adult patients (18 years or over)admitted to ICU with an expected stay of more than 48 hours. Patients who are commenced on enteral feeding via gastric or post pyloric routes. Patients who consent or if the patients is incompetent, their next of kin who consent, to inclusion in the study Exclusion Criteria: Patients less than 18 years old. Patients who are already receiving probiotic treatment. 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. 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. Patients with a contra-indication to enteral feeding. Patients with contra-indication to placement of enteral feeding tube. Patients or next-of-kin who do not consent to inclusion in the study. Patients who are already enrolled in another study that may influence the outcome of the probiotic study.

Sites / Locations

  • Intensive Care Unit Royal Melbourne Hospital Grattan Street

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

Standard Care

First active treatment

Second active reatment

Arm Description

Two capsules containing placebo will be given 12 hourly

Two capsules containing probiotic lactobacillus fermentin given 12 hourly

Two capsules containing probiotic lactobacillus acidiphilus given 12 hourly

Outcomes

Primary Outcome Measures

To determine if enteral feeding plus probiotic Lactobacilli are associated with a reduced rate of nosocomial pneumonia in critically ill patients.

Secondary Outcome Measures

To determine the incidence of complications of enteral feeding with and without added probiotic Lactobacilli.
To assess if the efficacy of enteral feeding in critically ill patients is improved by the addition of probiotic Lactobacilli.

Full Information

First Posted
November 17, 2005
Last Updated
November 18, 2015
Sponsor
Melbourne Health
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1. Study Identification

Unique Protocol Identification Number
NCT00256087
Brief Title
The Effect of Prophylactic Probiotic Lactobacilli in Enteral Feeding on Nosocomial Pneumonia Rates in Critically Ill Patients
Official Title
The Effect of Prophylactic Probiotic Lactobacilli in Enteral Feeding on Nosocomial Pneumonia Rates in Critically Ill Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Melbourne Health

4. Oversight

5. Study Description

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.
Detailed Description
The patients are randomised to one of three treatment groups. Each comprising of 100 patients. Standard therapy group. Patients will receive enteral feeding (with fibre) aiming at the target feeding rate that is determined by the treating physician and the ICU dietician, as is standard current practice. Two capsule containing placebo will be given 12 hourly via the feeding tube. The first active treatment group, will receive enteral feeding (with fibre) plus probiotic Lactobacillus fermentum included in the feeding regime. Two capsules containing Lactobacillus fermentum (10 11 organisms per capsule) will be delivered via the feeding tube 12 hourly. The second active treatment group will receive enteral feeding (with fibre) plus the probiotic Lactobacillus acidophilus included in the feeding regime. Two capsules containing Lactobacillus acidophilus (2x10 9 organisms per capsule) will be delivered via the feeding tube 12 hourly.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness
Keywords
Nosocomial rates in critically ill patients

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Care
Arm Type
Placebo Comparator
Arm Description
Two capsules containing placebo will be given 12 hourly
Arm Title
First active treatment
Arm Type
Active Comparator
Arm Description
Two capsules containing probiotic lactobacillus fermentin given 12 hourly
Arm Title
Second active reatment
Arm Type
Active Comparator
Arm Description
Two capsules containing probiotic lactobacillus acidiphilus given 12 hourly
Intervention Type
Drug
Intervention Name(s)
Probiotic Lactobacillus
Intervention Type
Other
Intervention Name(s)
Lactose Powder
Primary Outcome Measure Information:
Title
To determine if enteral feeding plus probiotic Lactobacilli are associated with a reduced rate of nosocomial pneumonia in critically ill patients.
Time Frame
28 days
Secondary Outcome Measure Information:
Title
To determine the incidence of complications of enteral feeding with and without added probiotic Lactobacilli.
Time Frame
28 Days
Title
To assess if the efficacy of enteral feeding in critically ill patients is improved by the addition of probiotic Lactobacilli.
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult patients (18 years or over)admitted to ICU with an expected stay of more than 48 hours. Patients who are commenced on enteral feeding via gastric or post pyloric routes. Patients who consent or if the patients is incompetent, their next of kin who consent, to inclusion in the study Exclusion Criteria: Patients less than 18 years old. Patients who are already receiving probiotic treatment. 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. 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. Patients with a contra-indication to enteral feeding. Patients with contra-indication to placement of enteral feeding tube. Patients or next-of-kin who do not consent to inclusion in the study. Patients who are already enrolled in another study that may influence the outcome of the probiotic study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Megan Robertson
Organizational Affiliation
Intensive Care Unit, Royal Melbourne Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Intensive Care Unit Royal Melbourne Hospital Grattan Street
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia

12. IPD Sharing Statement

Learn more about this trial

The Effect of Prophylactic Probiotic Lactobacilli in Enteral Feeding on Nosocomial Pneumonia Rates in Critically Ill Patients

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