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In vitro and in vivo safety analysis of Enterococcus faecium 2C isolated from human breast milk.

INTRODUCTION: Safety analysis of probiotic bacteria is an obligatory characteristic to be evaluated prior to application in food or pharmacological products. This study was designed to evaluate in vitro and in vivo safety parameters of Enterococcus faecium 2C strain, a probiotic candidate isolated from human breast milk.

MATERIAL AND METHODS: E.faecium 2C was studied for its hemolytic activity and phenotypic antibiotics resistance profile. In vivo safety of the mentioned Enterococcus strain was studied by determining acute oral toxicity in Wistar Male rats. The animals were randomly divided into two groups of 3 animals each. The test group animals were gavaged daily with bacterial dose of 1 × 1011  CFU/kg of animal body weight for 21 consecutive days. The animals in control group received normal basal diet without any supplementations. Hematological and biochemical parameters, organ weight, body weight and common health features of the animals were recorded.

RESULTS: E.faecium 2C appeared non-hemolytic and sensitive to the majority of the tested antibiotics. The Wistar male rats fed orally with the mentioned bacterial suspensions survived the test period, and showed normal growth and development. No adverse effects on the general health condition, behavior, and growth were seen in the treated animals compared to control group. Additionally, no significant changes in the hematological results, blood biochemistry, organ weights and histopathology of the rats in treatment groups were observed. None of the vital organs of the treated animals showed signs of bacteremia or infectivity.

CONCLUSION: E.faecium 2C strain isolated from human breast milk might be considered safe for use in probiotic formulations intended for man and animals.

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