The Effect of Prophylactic Probiotic Lactobacilli in Ente... | NCT00256087

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

NCT00256087

Sponsor

Melbourne Health

Status

Completed

Last Update Posted

Nov 20, 2015Estimated

Enrollment

57Actual

Phase

Not Applicable

Conditions

Critical Illness

Interventions

Probiotic Lactobacillus
Lactose Powder

Countries

Australia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2005

Primary Completion Date

Jan 2010Actual

Completion Date

Jan 2010Actual

First Submitted Date

Nov 17, 2005

First Submission Date that Met QC Criteria

Nov 17, 2005

First Posted Date

Nov 21, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 18, 2015

Last Update Posted Date

Nov 20, 2015Estimated

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

57Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Standard Care	Placebo Comparator	Two capsules containing placebo will be given 12 hourly	Other: Lactose Powder
First active treatment	Active Comparator	Two capsules containing probiotic lactobacillus fermentin given 12 hourly	Drug: Probiotic Lactobacillus
Second active reatment	Active Comparator	Two capsules containing probiotic lactobacillus acidiphilus given 12 hourly	Drug: Probiotic Lactobacillus

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Probiotic Lactobacillus	Drug		First active treatment Second active reatment
Lactose Powder

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To determine if enteral feeding plus probiotic Lactobacilli are associated with a reduced rate of nosocomial pneumonia in critically ill patients.		28 days

Secondary Outcomes

Measure	Description	Time Frame
To determine the incidence of complications of enteral feeding with and without added probiotic Lactobacilli.		28 Days
To assess if the efficacy of enteral feeding in critically ill patients is improved by the addition of probiotic Lactobacilli.		28 days

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Megan Robertson	Intensive Care Unit, Royal Melbourne Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Intensive Care Unit Royal Melbourne Hospital Grattan Street		Parkville	Victoria	3050	Australia

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms