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

摘要: Historically, bifidobacteria were the dominant intestinal bacteria in breastfed infants. Still abundant infants developing nations, levels of are low among developed nations. Recent studies have described an intimate relationship between human milk and a specific subspecies Bifidobacterium, B. longum subsp. infantis (B. infantis), yet supplementation breastfed, healthy, term with this organism, has not been reported. The IMPRINT Study, Phase I clinical trial, was initiated to determine safety tolerability supplementing (EVC001). Eighty mother-infant dyads enrolled either lactation support plus (BiLS) or alone (LS). Starting Day 7 postnatal, BiLS fed 1.8–2.8 × 1010 CFU EVC001 daily breast for 21 days. Mothers collected fecal samples, filled out health questionnaires, kept logs about their infants’ feeding gastrointestinal symptoms from birth until 61 postnatal. Safety determined maternal reports. There no differences mean gestational age at birth, weight 1 2 months intake groups. Log10 change Bifidobacterium 6 28 higher (p = 0.0002) (6.6 ± 2.8 SD) than LS (3.5 ± 3.5 SD). Daily stool number (p < 0.005) lower (p < 0.05) during Baseline. During supplementation, watery stools decreased soft increased by 36% over baseline significant changes consistency None endpoints, including flatulence, bloody stool, body temperature, ratings symptoms, use antibiotics gas-relieving medications, infant colic, jaundice, illnesses, sick doctor visits, diagnoses eczema different groups any point. supplement safely consumed well-tolerated. Stools fewer better formed group compared group. Adverse events those expected healthy ClinicalTrials.gov NCT02457338 . Registered May 27, 2015.