The Effect of Prophylactic Probiotic Lactobacilli in Enteral Feeding on Nosocomial Pneumonia Rates in Critically Ill Patients
The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Melbourne Health.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Melbourne Health
Information provided by:
Melbourne Health
ClinicalTrials.gov Identifier:
NCT00256087
First received: November 17, 2005
Last updated: February 3, 2009
Last verified: February 2009
Tracking Information | |||||||||
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First Received Date ICMJE | November 17, 2005 | ||||||||
Last Updated Date | February 3, 2009 | ||||||||
Start Date ICMJE | January 2005 | ||||||||
Primary Completion Date | |||||||||
Current Primary Outcome Measures ICMJE |
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 ] | ||||||||
Original Primary Outcome Measures ICMJE |
To determine if enteral feeding plus probiotic Lactobacilli are associated with a reduced rate of nosocomial pneumonia in critically ill patients. | ||||||||
Change History | Complete list of historical versions of study NCT00256087 on ClinicalTrials.gov Archive Site | ||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | |||||||||
Original Other Outcome Measures ICMJE | |||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | The Effect of Prophylactic Probiotic Lactobacilli in Enteral Feeding on Nosocomial Pneumonia Rates in Critically Ill Patients | ||||||||
Official Title ICMJE | The Effect of Prophylactic Probiotic Lactobacilli in Enteral Feeding on Nosocomial Pneumonia Rates in Critically Ill Patients | ||||||||
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. |
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Detailed Description | The patients are randomised to one of three treatment groups. Each comprising of 100 patients.
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Study Type ICMJE | Interventional | ||||||||
Study Phase | |||||||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Prevention |
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Condition ICMJE | Critical Illness | ||||||||
Intervention ICMJE | Drug: Probiotic Lactobacillus | ||||||||
Study Arm (s) | |||||||||
Publications * | |||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE | 300 | ||||||||
Completion Date | |||||||||
Primary Completion Date | |||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||||||
Ages | 18 Years and older | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts ICMJE |
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Location Countries ICMJE | Australia | ||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT00256087 | ||||||||
Other Study ID Numbers ICMJE | 2004.067 | ||||||||
Has Data Monitoring Committee | |||||||||
Responsible Party | |||||||||
Study Sponsor ICMJE | Melbourne Health | ||||||||
Collaborators ICMJE | |||||||||
Investigators ICMJE |
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Information Provided By | Melbourne Health | ||||||||
Verification Date | February 2009 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |