Safety, efficacy, and impact on gut microbial ecology of a subspecies LMG11588 supplementation in healthy term infants: a randomized, double-blind, controlled trial in the Philippines.

Introduction: subspecies infantis () may play a key role in infant gut development. This trial evaluated safety, tolerability, and efficacy of LMG11588 supplementation.

Methods: This randomized, placebo-controlled, double-blind study conducted in the Philippines included healthy breastfed and/or formula-fed infants (14-21 days old) randomized for 8 weeks to a control group (CG;  = 77), or any of two experimental groups (EGs): low (Lo-EG; 1*10 CFU/day;  = 75) or high dose (Hi-EG; 1.