Safety and efficacy of human breast milk Lactobacillus fermentum CECT 5716. A mini-review of studies with infant formulae

Human breast milk has been described as a source of lactic acid bacteria. Lactobacillus fermentum CECT5716 is a human breast milk strain whose probiotic properties, safety and efficacy has been demonstrated in vitro and in vivo , including controlled trials with human adults. Since the origin of this probiotic strain is human breast milk, we aimed to investigate the safety and efficacy of an infant and a follow-on formulas supplemented with this strain of L. fermentum . We carried out two randomised controlled trials: one trial with infants of 6-12 months of age (follow-on formula study) and another one with infants from 1 to 5 months of age (infant formula study). The results from the trials showed that the probiotic formulas were safe, well tolerated and might be useful for the prevention of community-acquired infections.