Baby Development
Gut Health
Published Research
The IMPRINT study was designed to understand the changes that feeding B. infantis EVC001 would have to the microbiome and gut biochemistry of breastfed infants.
The purpose of this clinical trial is to determine the effects of supplementing the probiotic Bifidobacterium longum subsp. infantis EVC001 for the first 21 days of life in healthy term breastfed infants delivered via C-section or vaginal delivery on gut bacteria composition compared with matched-control term infants receiving standard care. The specific aim of the study was to compare the fecal microbiota (total B. infantis, total Bifidobacterium, total bacteria and composition of microbiota) between the supplement and control groups.
7 different publications stemmed from this research, looking at different endpoints of the trial & the results are discussed below.
| IMPRINT (Infant Microbiota and Probiotic Intake) STUDY and subsequent Publications | |||
|---|---|---|---|
| Publication | Methods | Summary | Link |
| "Safety and tolerability of Bifidobacterium longum subspecies infantis EVC001 supplementation in healthy term breastfed infants: a phase I clinical trial", Smilowitz J, Moya J, Breck M, et al. 2017; 17.1 1-11. BMC Pediatrics | The IMPRINT study was a phase I clinical trial that was a parallel, randomized controlled study. Investigators recruited 80 mother- term infant dyads who received either lactation support plus daily B. infantis EVC001 (1.8–2.8 × 10^10 CFU) with breast milk starting on day 7, or lactation support alone. Fecal samples, health questionnaires, and daily feeding and GI logs were kept for 60 days. | Infants that received B. infantis EVC001 had a higher mean Log10 change in fecal Bifidobacterium from Day 6 to Day 28 compared to control infants (p = 0.0002). During supplementation, infants that received B. infantis EVC001 had lower daily number of stools (p < 0.05) and a 36% increase in soft stools (p < 0.05). There were no differences in safety or tolerability endpoints, including flatulence, bloody stool, body temperature, gastrointestinal symptoms, use of medications, infant colic, jaundice, illnesses, sick doctor visits, or eczema diagnoses. | https://link.springer.com/article/10.1186/s12887-017-0886-9 |
| "Persistence of Supplemented Bifidobacterium longum subsp. infantis EVC001 in Breastfed Infants", Frese et al. 2017 mSphere | Microbiome analysis using qPCR and 16S rRNA gene sequencing: study days 7 to 60 | Infants that received B. infantis EVC001 had significantly higher abundance of B. infantis (by qPCR) and relative abundance of Bifidobacterium (by 16S rRNA sequencing) compared to exclusively-breastfed infants not fed the probiotic. | https://journals.asm.org/doi/10.1128/msphere.00501-17 |
| "Colonization of breastfed infants by Bifidobacterium longum subsp. infantis EVC001 reduces virulence gene abundance", Casaburi, G. & Frese 2018 Human Microbiome Journal | Analysis of virulence factors in the microbiome from metagenomics sequencing on samples collected on study day 21 | After 21 days of receiving the probiotic B. infantis EVC001, infants had 90% less detectable antibiotic-resistant genes (ARGs) in their microbiomes compared to infants who did not receive the probiotic. | Colonization of breastfed infants by Bifidobacterium longum subsp. infantis EVC001 reduces virulence gene abundance - ScienceDirect |
| "Reduced colonic mucin degradation in breastfed infantscolonized by Bifidobacterium longum subsp. infantis EVC001", Karav et al. 2018 FEBS Open Bio | Mass spectrometry analysis of fecal samples obtained from nine infants colonized by B. infantis EVC001 and from 10 infants colonized by higher levels of mucolytic taxa (controls) | The abundance of colonic mucin-derived O-glycans was higher in the fecal samples of control infants, relative to those that received probiotic B. infantis EVC001. | https://febs.onlinelibrary.wiley.com/doi/epdf/10.1002/2211-5463.12516 |
| "Colonization by B. infantis EVC001 modulates enteric inflammation in exclusively breastfed infants", Henrick et al. 2019 Pediatric Research | Proinflammatory fecal cytokine profiling using immunoassays at three time points: days 6 (Baseline), 40, and 60 postnatal | Proinflammatory cytokines were significantly lower in B. infantis EVC001-fed infants on days 40 and 60 postnatally compared to baseline and compared to control infants. | https://www.nature.com/articles/s41390-019-0533-2.pdf |
| "Metagenomic insights of the infant microbiome community structure and function across multiple sites in the United States", Casaburi et al. 2019 Antibiotic Resistance & Infection Control | Analysis of antibiotic resistant genes in the microbiome from metagenomics sequencing on samples collected on study day 21 | Infants fed B. infantis EVC001 exhibited a change to the gut microbiome, resulting in a 90% lower level of antibiotic resistant genes compared to control infants. | https://www.nature.com/articles/s41598-020-80583-9.pdf |
| "Bifidobacteria-mediated immune system imprinting early in life", Henrick et al. 2021 Cell | Multi-immune profiling on fecal samples obtained on days 6 (Baseline), 40, and 60 postnatal and in vitro assays using fecal water from EVC001-supplemented infants | EVC001-associated indole-3-lactic acid was found to upregulate inhibitory galectin-1 in Th2 and Th17 cells, providing a functional link between EVC001-derived metabolites, and immunoregulation during the first critical months of life. Intestinal T helper 2 (Th2) and Th17 cytokines were silenced and interferon β (IFNβ) was induced in infants supplemented with B. infantis EVC001 compared to control infants. | https://www.sciencedirect.com/science/article/pii/S0092867421006607 |
| "Early probiotic supplementation with B. infantis in breastfed infants leads to persistent colonization at 1 year", O’Brien et al.2021 Pediatric Research | A 2-year follow-up study to IMPRINT: In the follow-up study, mothers (n = 48) collected infant stool at 4, 6, 8, 10, and 12 months postnatal and completed the healthdiet questionnaires. | Probiotic supplementation with B. infantis EVC001 within the first month postnatal, in combination with breast milk, resulted in stable colonization that persisted until at least 1 year postnatal. | https://www.infinanthealth.com/hubfs/s41390-020-01350-0.pdf |
Why are they passionate about Evivo?
Dr. Albert Antonio
“Evivo and its role in supporting the infant gut microbiome is an example of thoughtfully harnessing the synergy between nature and our best understanding of the developing infant immune system to support the growth of all babies. The microbiome science resonates with my research experience with neonatal immunology and microbiology and passion for caring for babies.”
Neonatologist & Pediatrician
Dad of 2
Carrie McGuckin, RNC-NIC
“I never thought I would leave the bedside, but the science behind Evivo really intrigued me. The more I learned and the more I saw actual benefits, the more I knew I had to be involved in this mission to get B. infantis back into babies everywhere. Evivo is putting back what nature intended to be present in the first place. I love that it is so simple and yet the impacts can have such potential to change baby’s lives for the better.”
BSN, Certified Nurse for Neonatal Intensive Care
Director of Corporate Excellence
Mom of 3
