Colonization by B. infantis EVC001 modulates enteric inflammation in exclusively breastfed infants

Pediatr Res. 2019 Dec;86(6):749-757. doi: 10.1038/s41390-019-0533-2. Epub 2019 Aug 23.


Background: Infant gut dysbiosis, often associated with low abundance of bifidobacteria, is linked to impaired immune development and inflammation-a risk factor for increased incidence of several childhood diseases. We investigated the impact of B. infantis EVC001 colonization on enteric inflammation in a subset of exclusively breastfed term infants from a larger clinical study.

Methods: Stool samples (n = 120) were collected from infants randomly selected to receive either 1.8 × 1010 CFU B. infantis EVC001 daily for 21 days (EVC001) or breast milk alone (controls), starting at day 7 postnatal. The fecal microbiome was analyzed using 16S ribosomal RNA, proinflammatory cytokines using multiplexed immunoassay, and fecal calprotectin using ELISA at three time points: days 6 (Baseline), 40, and 60 postnatal.

Results: Fecal calprotectin concentration negatively correlated with Bifidobacterium abundance (P < 0.0001; ρ = -0.72), and proinflammatory cytokines correlated with Clostridiaceae and Enterobacteriaceae, yet negatively correlated with Bifidobacteriaceae abundance. Proinflammatory cytokines were significantly lower in EVC001-fed infants on days 40 and 60 postnatally compared to baseline and compared to control infants.

Conclusion: Our findings indicate that gut dysbiosis (absence of B. infantis) is associated with increased intestinal inflammation. Early addition of EVC001 to diet represents a novel strategy to prevent enteric inflammation during a critical developmental phase.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Bifidobacterium longum subspecies infantis / growth & development*
  • Breast Feeding*
  • Cytokines / metabolism
  • Enteritis / metabolism
  • Enteritis / microbiology
  • Enteritis / prevention & control*
  • Feces / chemistry
  • Feces / microbiology
  • Female
  • Gastrointestinal Microbiome
  • Humans
  • Infant, Newborn
  • Inflammation Mediators / metabolism
  • Leukocyte L1 Antigen Complex / analysis
  • Male
  • Prospective Studies


  • Cytokines
  • Inflammation Mediators
  • Leukocyte L1 Antigen Complex