Safety and tolerability of Bifidobacterium longum subspecies infantis EVC001 supplementation in healthy term breastfed infants: a phase I clinical trial.

ABSTRACT:

Background

Historically, bifidobacteria were the dominant intestinal bacteria in breastfed infants. Still abundant in infants in developing nations, levels of intestinal bifidobacteria are low among infants in developed nations. Recent studies have described an intimate relationship between human milk and a specific subspecies of Bifidobacterium, B. longum subsp. infantis (B. infantis), yet supplementation of breastfed, healthy, term infants with this organism, has not been reported. The IMPRINT Study, a Phase I clinical trial, was initiated to determine the safety and tolerability of supplementing breastfed infants with B. infantis (EVC001).

Methods

Eighty mother-infant dyads were enrolled in either lactation support plus B. infantis supplementation (BiLS) or lactation supp

SUBMITTER: Smilowitz JT 

PROVIDER: S-EPMC5450358 | biostudies-literature | 2017 May

REPOSITORIES: biostudies-literature