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.