The Effect of Prophylactic Pre Operative Probiotic Therapy on Endotoxin Levels in Cardiac Surgery Patients
NCT ID: NCT00256022
Last Updated: 2015-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2007-07-31
2007-12-31
Brief Summary
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Endotoxins are large heat stable lipopolysaccharides, which are found in the cell wall of gram negative bacteria. It has been assumed that the intestinal bacteria are the primary source of the plasma endotoxin in cardiac surgery patients.Lactobacilli have been reported as effective in counteracting gram negative bacteria in the gut.Thus Lactobacilli may be effective in reducing the endotoxin rise associated with cardiopulmonary bypass, which may potentially reduce the incidence of the syndrome of generalised inflammation and low systemic vascular resistance post cardiopulmonary bypass.
Detailed Description
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Two different lactobacillus strains will be assessed in the study: Lactobacillus Acidophilus and Lactobacillus Fermentum. There are 4 treatment groups in this study. Lactobacillus Acidophilus,Lactobacillus Fermentum, Lactobacillus Fermentum and Lactobacillus Acidophilus and Placebo.
The probiotic/placebo will be given to the patient 2 a dy for between 2-7 days preoperatively. Participation in this study requires 6 separate blood tests commencing at the start of surgery and continuing for 24 hours immediately post operatively.A total of 30 mls of blood is required.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Lactobacillus Acidophilus Arm
The probiotic will be given to the patient 2 a dy for between 2-7 days preoperatively. Participation in this study requires 6 separate blood tests commencing at the start of surgery and continuing for 24 hours immediately post operatively.
Lactobacillus Probiotic
Lactobacillus Fermentum Arm
The probiotic will be given to the patient 2 a dy for between 2-7 days preoperatively. Participation in this study requires 6 separate blood tests commencing at the start of surgery and continuing for 24 hours immediately post operatively.
Lactobacillus Probiotic
Lactobacillus Fermentum and Lactobacillus Acidophilus
The probiotic will be given to the patient 2 a dy for between 2-7 days preoperatively. Participation in this study requires 6 separate blood tests commencing at the start of surgery and continuing for 24 hours immediately post operatively.
Lactobacillus Probiotic
Placebo
The placebo will be given to the patient 2 a day for between 2-7 days preoperatively. Participation in this study requires 6 separate blood tests commencing at the start of surgery and continuing for 24 hours immediately post operatively.
Lactose Powder
Interventions
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Lactobacillus Probiotic
Lactose Powder
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Current usage of a probiotic product
* Past history of asthma or recurrent urticaria, pregnancy, HIV infection, immunosuppression and pre existing intestinal disorder.
The Lactobacillus acidophilus preparation to be used in this study contains a very small amount of MSG (total dose 20mg/day, equivalent to 10% of the total dose used to test MSG sensitivity) and as a precaution patients with asthma or recurrent urticaria will be excluded. As the Lactobacillus preparation contains live micro organisms, immunosuppressed and pregnant patients will be excluded.
18 Years
ALL
No
Sponsors
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Intensive Care Unit Research Department, Royal Melbourne Hospital
UNKNOWN
Melbourne Health
OTHER
Principal Investigators
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John F Cade
Role: PRINCIPAL_INVESTIGATOR
Intensive Care Unit, Royal Melbourne Hospital
Other Identifiers
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2000.177
Identifier Type: -
Identifier Source: org_study_id