Praxis Medical Insights

Est. 2024 • Clinical Guidelines Distilled

Made possible by volunteer editors from the University of Calgary & University of Alberta

Last Updated: 12/20/2025

Bifidobacterium animalis Safety and Efficacy in Preterm Neonates

Introduction to Bifidobacterium animalis

  • The American Gastroenterological Association recommends B. animalis subsp. lactis for prevention of necrotizing enterocolitis (NEC) and all-cause mortality in preterm neonates (<37 weeks gestational age, low birth weight) based on moderate-to-high quality evidence 1, 2, 3

Evidence-Based Recommendations

  • B. animalis subsp. lactis reduces all-cause mortality (OR 0.56, 95% CI 0.39-0.80) in preterm neonates (<37 weeks gestational age, low birth weight) 2, 3
  • B. animalis subsp. lactis alone reduces severe NEC (OR 0.31, 95% CI 0.13-0.74) with moderate-to-high quality evidence in preterm neonates (<37 weeks gestational age, low birth weight) 2
  • B. animalis subsp. lactis significantly reduces days of hospitalization (MD -13.00 days, 95% CI -22.71 to -3.29) with high certainty of evidence in preterm neonates (<37 weeks gestational age, low birth weight) 4, 5

Specific Strain Recommendations

  • B. animalis subsp. lactis DSM 15954 is recommended as a single-strain probiotic for preterm neonates (<37 weeks gestational age, low birth weight) 2
  • Combination products containing B. animalis subsp. lactis with Lactobacillus acidophilus, B. bifidum, and B. longum subsp. longum are recommended for preterm neonates (<37 weeks gestational age, low birth weight) 2

Microbiome Effects Supporting Safety

  • B. animalis demonstrates favorable colonization patterns in preterm infants, showing stronger maintenance of abundance compared to Lactobacillus species 6, 7
  • B. animalis supplementation decreases potentially pathogenic bacteria, particularly Gammaproteobacteria and Klebsiella species, in preterm infants 6, 8, 9
  • B. animalis promotes accelerated transition toward a more mature, stable gut microbial ecosystem resembling term infants in preterm neonates (<37 weeks gestational age, low birth weight) 8, 9

Safety Profile

  • Probiotics do not increase sepsis risk in preterm neonates (<37 weeks gestational age, low birth weight) based on evidence from >10,000 preterm infants 2, 4, 5
  • Product quality is essential, as manufacturing contaminants have caused fatal infections in preterm neonates (<37 weeks gestational age, low birth weight) 4, 5

Contraindications and Cautions

  • Exercise caution in immunocompromised patients, critically ill patients with indwelling central venous catheters, infants with cardiac valvular disease, and infants with short-gut syndrome when using B. animalis supplementation 4, 10, 2

Practical Implementation

  • Verify gestational age <37 weeks and low birth weight as the target population for B. animalis supplementation 1
  • Choose pharmaceutical-grade products when available rather than dietary supplements for preterm neonates (<37 weeks gestational age, low birth weight)
  • Consider combination products with Lactobacillus species, which may provide additional benefits for preterm neonates (<37 weeks gestational age, low birth weight) 2, 3
  • Ensure product quality verification and absence of contaminants for preterm neonates (<37 weeks gestational age, low birth weight) 4, 5

Probiotics in Preterm Infants

Evidence for Probiotic Use

  • Probiotics containing bifidobacteria are superior to those containing lactobacilli for preterm infants, with benefits including prevention of NEC, late-onset sepsis, feeding intolerance, and mortality, according to the Gut Microbes journal 11, 12, 13
  • The evidence for preterm infants shows probiotics shift the microbiome toward one harboring fewer pathobionts and greater beneficial microbes, as reported in Gut Microbes 12, 13

REFERENCES

10

Probiotic Use of Lactobacillus rhamnosus and Lactobacillus acidophilus [LINK]

Praxis Medical Insights: Practical Summaries of Clinical Guidelines, 2025