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Addressing safety concerns of probiotic use in preterm babies

Paul F Fleming1, Janet E Berrington2, Susan E Jacobs3

  • 1Homerton University Hospital NHS Foundation Trust, London, UK; Barts and the London School of Medicine and Dentistry, London, UK.

Early Human Development
|June 4, 2019
PubMed

Insights

Probiotics are safe for preterm infants, with over 10,000 enrolled in trials for preventing necrotising enterocolitis and few adverse events. This review examines potential risks and safety data for live microbial products in neonates.

Area of Science:

  • Neonatal Medicine
  • Microbiology
  • Clinical Trials

Background:

  • Necrotising enterocolitis (NEC) is a significant concern in preterm infants.
  • Probiotics are explored as a preventative measure for NEC.
  • Concerns about probiotic safety persist despite extensive research.

Purpose of the Study:

  • To review the safety of probiotic administration in preterm infants.
  • To address the perceived risks associated with live microbial products in neonates.
  • To examine short- and longer-term safety data and regulatory considerations.

Main Methods:

  • Systematic review of clinical trial data.
  • Analysis of reported adverse events in preterm infants receiving probiotics.
  • Evaluation of regulatory guidelines for probiotic products.

Main Results:

  • Over 10,000 preterm infants have participated in trials.
  • Very few adverse events have been reported in association with probiotic use.
  • The review consolidates existing safety data and regulatory frameworks.

Conclusions:

  • Probiotic administration appears safe for preterm infants regarding NEC prevention.
  • Addressing safety concerns requires understanding potential risks and robust regulatory oversight.
  • Further research may refine optimal use and safety profiles of probiotics in neonates.

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