Evaluation of the safety, tolerance and efficacy of 1-year consumption of infant formula supplemented with Lactobacillus fermentum CECT5716 Lc40 or Bifidobacterium breve CECT7263: a randomized controlled trial
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AuthorMaldonado Lozano, José; Gil Campos, Mercedes; Maldonado Lobón, José Antonio; Benavides, M. R.; Flores-Rojas, Katherine; Jaldo, R.; Jiménez Del Barco Jaldo, Luis Miguel; Bolívar, V.; Valero, A. D.; Prados, E.; Peñalver, I.; Olivares, M.
Maldonado, J., Gil-Campos, M., Maldonado-Lobón, J. A., Benavides, M. R., Flores-Rojas, K., Jaldo, R., ... & Peñalver, I. (2019). Evaluation of the safety, tolerance and efficacy of 1-year consumption of infant formula supplemented with Lactobacillus fermentum CECT5716 Lc40 or Bifidobacterium breve CECT7263: a randomized controlled trial. BMC pediatrics, 19(1), 361.
SponsorshipThis work was funded by Biosearch Life supported by a grant from the Agency of Innovation and Development of Andalusia (IDEA-Spain), Cofinanced by European Regional Development Fund (EC). Project Tittle: “New applications of probiotic strains and derived compounds with biological activity (POSTBIO)” and partially funded by Lactalis-Puleva (Granada, Spain).
Background: The microorganism present in breast milk, added to other factors, determine the colonization of infants. The objective of the present study is to evaluate the safety, tolerance and effects of the consumption of a milk formula during the first year of life that is supplemented with L. fermentum CECT5716 or Bifidobacterium breve CECT7263, two strains originally isolated from breast milk. Results: One hundred and eighty-nine infants completed the eleven months of intervention (61 in control group, 65 in Lf group and 63 in Bb group). The growth of infants in the three groups was consistent with standards. No significant differences were observed in the main outcome, weight-gain (Control group: 5.77 Kg ± 0.95, Lf group: 5.77 Kg ± 1.31, Bb group: 5.58 Kg ± 1.10; p = 0.527). The three milk formulae were well tolerated, and no adverse effects were related to the consumption of any of the formula. Infants receiving B. breve CECT7263 had a 1.7 times lower risk of crying than the control group (OR = 0.569, CI 95% 0.568–0.571; p = 0.001). On the other hand, the incidence of diarrhoea in infants receiving the formula supplemented with L. fermentum CECT5716 was a 44% lower than in infants receiving the control formula (p = 0.014). The consumption of this Lactobacillus strain also reduced the duration of diarrhoea by 2.5 days versus control group (p = 0.044). Conclusions: The addition of L. fermentum CECT5716 Lc40 or B. breve CECT7263, two probiotic strains naturally found in breast milk, to infant formulae is safe and induces beneficial effects on the health of infants.