drugset / Trial / NCT00256022

The Effect of Prophylactic Pre Operative Probiotic Therapy on Endotoxin Levels in Cardiac Surgery Patients

NCT00256022 ↗

RandomizedParallel-groupDouble-blindPrevention

Summary

The primary hypothesis for the study is that pre-operative prophylactic probiotic Lactobacilli tablets will reduce the severity and incidence of endotoxin rise in post cardiopulmonary bypass in cardiac surgery patients. 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.

Timeline

Start
2007-07
Primary completion
—
Completion
2007-12

Outcome

Outcome not reported

Stopped: “Due to delays with logistics and protocol revision not viable to continue.”

Drugs

EvaluationDrugModalityDoseRoute
Comparator Lactobacillus Fermentum Other / unclassified — —
Comparator Lactobacillus acidophilus Other / unclassified — —

Indications

No indication recorded.