J Fonolla1, J A Maldonado-Lobon1, M Gil-Campos2, J Maldonado3, K Flores2, M R Benavides4, R Jaldo5, I Jimenez del Barco6, V Bolivar5, E Prados5, I Penalver5, M Molina5, J M Fernandez5, J L Garcia-Salmeron5, F J Garrido5, A D Valero3, F Lara-Villoslada7 and M Olivares3
1Biosearch Life, Spain
2Hospital Reina SofÃ?Â?Ã?Âa, Spain
3Hospital Universitario Virgen de las Nieves, Spain
4ClÃ?Â?Ã?Ânica PediÃ?Â?Ã?¡trica Roquetas, Spain
5Servicio Andaluz de Salud, Spain
6PoliclÃ?Â?Ã?Ânica Crist
Posters-Accepted Abstracts: J Prob Health
Objective: To evaluate the safety and tolerance of the consumption of the probiotic strain B. breve CECT7263 supplemented in an infant formula in infants from 1 to 12 months of life. Methods: A multicenter randomized double blinded controlled study including 154 neonates at the age of 1 month was conducted. Infants were assigned randomly to either the Probiotic group (infant formula supplemented with B. breve) or the control group (same formula without probiotic). The primary aim of the study was the growth of infants. Secondary outcomes were flatulence, regurgitation and bouts of crying. This study was carried out according to the Helsinki declaration and the protocol was approved by the Regional Ethics Committee of the Sistema Andaluz de Salud based in Seville (Spain). Results: No significant changes between groups were observed in weight, length or head circumference. The z-scores of weight, length and head circumference for age were calculated based on the WHO Child Growth Standards. The population of the study did not differ from the standard and no significant differences were detected between the groups of the study. No significant differences were observed in the odds to suffering flatulence or regurgitation. However, infants receiving the probiotic strain had lower risk of bouts of crying (infant colic) (p<0.001). Conclusion: The consumption from 1 to 12 months of life of an infant formula enriched with the human milk probiotic strain Bifidobacterium breve CECT7263 is safe in neonates and improve symptoms of infant colic.
