None listed
Conditions
Interventions
This is a randomised double blind placebo-controlled study assessing blood endotoxin levels in cardiac surgery patients requiring cardiopulmonary bypass. This study compares endotoxin levels of post operative cardiac surgery patients who have received pre-operative prophylactic probiotic Lactobacillus tablets compared with patients who have received a placebo. Two different Lactobacillus strains will be assessed in the study, Lactobacillus acidophilus and Lactobacillus fermentum.There are 4
This is a randomised double blind placebo-controlled study assessing blood endotoxin levels in cardiac surgery patients requiring cardiopulmonary bypass. This study compares endotoxin levels of post operative cardiac surgery patients who have received pre-operative prophylactic probiotic Lactobacillus tablets compared with patients who have received a placebo. Two different Lactobacillus strains will be assessed in the study, Lactobacillus acidophilus and Lactobacillus fermentum.There are 4 treatment groups in this study:Lactobacillus Fermentum, lactobacillus acidophillus, lactobacillus fermentum and acidophillus and placebo. The lactobacillus/placebo will be given to patients twice a day for between 2 to 7 days pre-operatively.Participation in the study requires six separate blood tests commencing at the start of surgery and continuing for the first 24 hours immediately post-operatively. Each blood test requires 5 mls of blood, with a total blood volume of 30 mls required for the study.
Sponsors
Intensive Care Unit, RMH
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients scheduled for elective cardiac surgery requiring cardiopulmonary bypass will be approached for consent to participate in the study.
Exclusion criteria
Current usage of a probiotic product (eg Yakult, which is freely available as a foodstuff), past history of asthma or recurrent urticaria, pregnancy, HIV infection, immunosupression and pre-existing intestinal disorder. The Lactobacillus acidophilus preparation to be used in this study contains a very small amount of MSG (total dose 20 mg/day, equivalent to 10% of the initial dose used to test for MSG sensitivity) and as a precaution, patients with asthma or recurrent urticaria will be excluded. As the Lactobacillus preparation contains live microrganisms, immunosupressed and pregnant patients will also be excluded.
Outcome results
None listed