Bifidobacterium longum subsp infantis CECT7210 supplemented formula reduces diarrhoea in healthy infants: a randomized controlled trial.
Pediatr Res. 2018 Mar 14. Epub 2018 Mar 14. PMID: 29538368
BACKGROUND: Intestinal microbiota of breast-fed infants is plenty of beneficial bifidobacteria. We aimed to determine whether an infant formula supplemented with probiotic Bifidobacterium longum subsp. infantis CECT7210 (B. infantis IM1®) is effective at reducing diarrhoea incidence in healthy term infants.
METHODS: Double-blinded, randomized, multicentre, controlled clinical trial, where formula-fed infants (<3 months) received an infant formula supplemented (Probiotic) or not (Control) with 10cfu/g of B. infantis IM1® over 12 weeks. Diarrhoeas, growth, digestive symptoms, stool bifidobacteria and microbiota were assessed.
RESULTS: 97 (Control) and 93 (Probiotic) infants were randomized, 78 (Control) and 73 (Probiotic) completed the 12 weeks follow-up. In the overall study period, a median of 0.29±1.07 and 0.05±0.28 diarrhoea events/infant was observed in the Control and Probiotic groups respectively (p=0.059). This trend to less diarrhoea episodes in the Probiotic group reached statistical significance at 8 weeks (0.12±0.47 vs. 0.0±0.0 events/infant, P=0.047). Constipation incidence washigher (OR 2.67 (1.09-6.50)) and stool frequency lower (2.0±1.0 vs. 2.6±1.3 stools/day, P=0.038) in the Control group after 4 weeks. No differences were found at other timepoins nor in other digestive symptoms, growth or formula intake.
CONCLUSIONS: A B. infantis IM1®-supplemented infant formula may reduce diarrhoea episodes; being safe, well tolerated and associated with lower constipation prevalence.Pediatric Research accepted article preview online, 14 March 2018. doi:10.1038/pr.2018.34.