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Published on: January 27, 2019

Safety, tolerability, and gastrointestinal effect of a Bifidobacterium-based synergistic synbiotic in infants and

John B Jarman1, Pedro J Torres1, Charles Baum2

  • 1Persephone Biosciences, San Diego, CA, USA.

Pediatric Research
|August 12, 2026
PubMed

Insights

A novel synbiotic supplement safely enhanced Bifidobacterium colonization in infants and toddlers, improving gut health and, in toddlers, sleep quality. This study demonstrates sustained gut microbiome support beyond active supplementation.

Area of Science:

  • Microbiology
  • Pediatrics
  • Gastroenterology

Background:

  • Bifidobacterium are essential for infant gut health but are often deficient in developed countries.
  • The ARTEMIS trial addresses this deficiency by evaluating a novel synbiotic supplement.

Purpose of the Study:

  • To assess the safety, tolerability, and efficacy of a synbiotic supplement in establishing Bifidobacterium colonization in infants and toddlers.
  • To evaluate the impact of the synbiotic on gut microbiome composition and function.

Main Methods:

  • A randomized, double-blind, placebo-controlled trial (ARTEMIS trial) involving 114 infants and toddlers.
  • The synbiotic contained four Bifidobacterium strains, four human milk oligosaccharides (HMOs), and vitamin D.
  • Safety, tolerability, and gastrointestinal colonization were assessed over the study period.

Main Results:

  • The synbiotic was safe and well-tolerated, with no significant differences in adverse events compared to placebo.
  • Significant increases in the prevalence and abundance of administered Bifidobacterium strains were observed.
  • Sustained colonization was demonstrated, with increased abundance of HMO-utilization genes and improved sleep in toddlers.

Conclusions:

  • The tested synbiotic is safe and well-tolerated in infants and toddlers.
  • The synbiotic effectively promotes sustained Bifidobacterium colonization and modulates gut microbiome function.
  • This intervention shows promise for improving infant gut health and well-being.
Abstract

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