Quality of probiotic products for preterm infants: Contamination and missing strains

Marijn J Vermeulen1, Ad Luijendijk2, Letty van Toledo3

  • 1Division of Neonatology, Department of Paediatrics, Erasmus MC Sophia Children's Hospital, Rotterdam, The Netherlands.

Insights

Contaminated probiotic products pose risks in neonatal care. Routine safety checks are crucial for vulnerable infants, alongside manufacturer quality reports, due to potential pathogenic bacteria and missing strains.

Area of Science:

  • Neonatal Medicine
  • Microbiology
  • Pharmaceutical Quality Control

Background:

  • Probiotics show efficacy in preventing necrotising enterocolitis in preterm infants.
  • Routine probiotic use in neonates is not widely adopted.
  • Concerns exist regarding the quality and safety of probiotic products.

Purpose of the Study:

  • To highlight a safety issue with a widely used probiotic in neonatal care.
  • To emphasize the need for independent safety checks of probiotic products.
  • To advocate for collaboration on defining quality standards for clinical probiotics.

Main Methods:

  • Description of a specific safety incident involving a probiotic product.
  • Analysis of contamination by pathogenic bacteria.
  • Verification of labelled probiotic strains.

Main Results:

  • A widely used probiotic product was found to be contaminated with pathogenic bacteria.
  • The product also contained missing labelled strains.
  • This indicates a significant safety concern for vulnerable preterm infants.

Conclusions:

  • Independent product safety checks are essential for probiotics used in neonatal care.
  • Clinicians and manufacturers must collaborate to establish quality standards.
  • Addressing these issues is critical in the absence of specific international regulations.

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