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Updated: May 5, 2026

Probiotic Studies in Neonatal Mice Using Gavage
Published on: January 27, 2019
Efficacy and safety of probiotics in preterm infants
1Division of Neonatology, Department of Pediatrics, King Saud University, Riyadh, Saudi Arabia.
Insights
Enteral probiotic supplementation significantly reduced severe necrotizing enterocolitis and mortality in infants. This meta-analysis of nineteen trials confirms probiotics are generally safe for infants, with no increased risk of systemic infection.
Area of Science:
- Neonatal Medicine
- Microbiology
- Gastroenterology
Background:
- Probiotics are live microbial supplements that enhance gut health.
- Necrotizing enterocolitis (NEC) and mortality are significant risks for premature infants.
- Previous studies suggested potential benefits of probiotics in infant gut health.
Purpose of the Study:
- To systematically review and meta-analyze the efficacy and safety of enteral probiotic supplementation in infants.
- To assess the impact of probiotics on severe necrotizing enterocolitis, mortality, and nosocomial sepsis.
- To evaluate the risk of systemic infections associated with probiotic use in neonates.
Main Methods:
- Updated systematic review and meta-analysis of nineteen randomized controlled trials.
- Inclusion of over 2800 infants across the analyzed trials.
- Statistical analysis using typical risk ratios (RR) and 95% confidence intervals (CI).
Main Results:
- Enteral probiotic supplementation significantly reduced the incidence of severe necrotizing enterocolitis (RR 0.35, 95% CI 0.24 to 0.52).
- Mortality was significantly reduced in infants receiving probiotics (RR 0.55, 95% CI 0.40 to 0.74).
- No significant reduction in nosocomial sepsis was observed (RR 0.89, 95% CI 0.77 to 1.03), and no systemic infections were reported.
Conclusions:
- Enteral probiotics are effective in reducing severe NEC and mortality in infants.
- Probiotic supplementation is generally considered safe for infants, with no evidence of increased systemic infection risk.
- Findings support the use of probiotics as a beneficial intervention in neonatal care, aligning with ESPGHAN recommendations.
Abstract:
Probiotics are live microbial feed supplements that beneficially affect the recipient by improving intestinal balance. In an updated systematic review, nineteen trials randomizing more than 2800 infants were included. In a meta-analysis of trial data, enteral probiotic supplementation significantly reduced the incidence of severe necrotizing enterocolitis (typical RR 0.35, 95% CI 0.24 to 0.52) and mortality (typical RR 0.55, 95% CI 0.40 to 0.74). There was no evidence of significant reduction of nosocomial sepsis (typical RR 0.89, 95% CI 0.77 to 1.03). The included trials reported no systemic infection with - supplemented probiotics. Recent data in addition to a report by the European Society for Pediatric Gastroenterology (ESPGAN) concluded probiotics could be generally considered safe.
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