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

  • 2017-05-30
  • BMC Pediatrics 17(1)
    • J. Smilowitz
    • Jackelyn Moya
    • Melissa A. Breck
    • Chelsea Cook
    • A. Fineberg
    • K. Angkustsiri
    • M. Underwood

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 support alone (LS). Starting with Day 7 postnatal, BiLS infants were fed 1.8-2.8 × 1010 CFU B. infantis EVC001 daily in breast milk for 21 days. Mothers collected fecal samples, filled out health questionnaires, and kept daily logs about their infants' feeding and gastrointestinal symptoms from birth until Day 61 postnatal. Safety and tolerability were determined from maternal reports.

Results: There were no differences in the mean gestational age at birth, weight 1 and 2 months postnatal, and breast milk intake between groups. The mean Log10 change in fecal Bifidobacterium from Day 6 to Day 28 was higher (p = 0.0002) for BiLS (6.6 ± 2.8 SD) than for LS infants (3.5 ± 3.5 SD). Daily stool number was higher (p < 0.005) for LS and lower (p < 0.05) for BiLS infants during supplementation than at Baseline. During supplementation, watery stools decreased and soft stools increased by 36% over baseline in BiLS infants (p < 0.05) with no significant changes in stool consistency for the LS infants. None of the safety and tolerability endpoints, including flatulence, bloody stool, body temperature, ratings of gastrointestinal symptoms, use of antibiotics or gas-relieving medications, infant colic, jaundice, number of illnesses, sick doctor visits, or diagnoses of eczema were different for the groups at any point.

Conclusions: The B. infantis EVC001 supplement was safely consumed and well-tolerated. Stools were fewer and better formed in infants in the BiLS group compared with LS group. Adverse events were those expected in healthy infants and not different between groups.

Trial registration: ClinicalTrials.gov NCT02457338 . Registered May 27, 2015.

Keywords: Bifidobacterium longum subspecies infantis; Breast milk; Gut microbiome; Human milk oligosaccharides; Infant; Probiotics; Supplementation; Tolerability.

Research Insights

SupplementHealth OutcomeEffect TypeEffect Size
Bifidobacterium infantisImproved Stool QualityBeneficial
Moderate
Bifidobacterium infantisIncreased Fecal Bifidobacteria LevelsBeneficial
Large
Bifidobacterium infantisNo Adverse Health EffectsNeutral
Large
Bifidobacterium infantisReduced Stool FrequencyNeutral
Moderate
Bifidobacterium infantis BI02Improved Stool ConsistencyBeneficial
Moderate
Bifidobacterium infantis BI02Increased Fecal Bifidobacteria LevelsBeneficial
Large
Bifidobacterium infantis BI02No Adverse Health EffectsNeutral
Large
Bifidobacterium infantis BI02Reduced Stool FrequencyNeutral
Moderate
Bifidobacterium infantis HA-116Improved Stool FormationBeneficial
Moderate
Bifidobacterium infantis HA-116Increased Bifidobacterium LevelsBeneficial
Large
Bifidobacterium infantis HA-116Reduced Mean Number of Stools per DayBeneficial
Moderate
Bifidobacterium infantis M-63Improved Stool ConsistencyBeneficial
Moderate
Bifidobacterium infantis M-63Increased Adverse EventsNeutral
Large
Bifidobacterium infantis M-63Increased Fecal Bifidobacterium LevelsBeneficial
Large
Bifidobacterium infantis M-63Reduced Mean Number of Stools per DayBeneficial
Moderate
Bifidobacterium infantis MAK22B04IImproved Stool ConsistencyBeneficial
Moderate
Bifidobacterium infantis MAK22B04IIncreased Fecal Bifidobacteria LevelsBeneficial
Large
Bifidobacterium infantis MAK22B04INo Change in Adverse EventsNeutral
Small
Bifidobacterium infantis MAK22B04IReduced Bowel MovementsBeneficial
Moderate
Bifidobacterium infantis SD-6720Improved Stool FormationBeneficial
Moderate
Bifidobacterium infantis SD-6720Increased Fecal Bifidobacteria LevelsBeneficial
Large
Bifidobacterium infantis SD-6720Reduced Stool FrequencyNeutral
Moderate
Bifidobacterium infantis VPro 53Improved Stool ConsistencyBeneficial
Moderate
Bifidobacterium infantis VPro 53No Significant Adverse EventsNeutral
Large
Bifidobacterium infantis VPro 53Reduced Stool FrequencyNeutral
Moderate
Bifidobacterium longum B1-05Improved Stool ConsistencyBeneficial
Moderate
Bifidobacterium longum B1-05Increased Fecal Bifidobacteria LevelsBeneficial
Large
Bifidobacterium longum B1-05No Change in Adverse EventsNeutral
Small
Bifidobacterium longum B1-05Reduced Bowel MovementsBeneficial
Moderate
Bifidobacterium longum SD-5588Improved Stool ConsistencyBeneficial
Moderate
Bifidobacterium longum SD-5588Increased Fecal Bifidobacteria LevelsBeneficial
Large
Bifidobacterium longum SD-5588Reduced Stool FrequencyNeutral
Moderate
Bifidobacterium longum subsp. infantisImproved Stool ConsistencyBeneficial
Moderate
Bifidobacterium longum subsp. infantisNo Significant Adverse EventsNeutral
Large
Bifidobacterium longum subsp. infantisReduced Stool FrequencyNeutral
Moderate
Bifidobacterium longum subsp. infantis M-63Absence of Adverse EffectsNeutral
Large
Bifidobacterium longum subsp. infantis M-63Improved Stool ConsistencyBeneficial
Moderate
Bifidobacterium longum subsp. infantis M-63Increased Fecal Bifidobacteria LevelsBeneficial
Large
Bifidobacterium longum subsp. infantis M-63Reduced Stool FrequencyNeutral
Moderate
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