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Updated: Jan 20, 2026

Author Spotlight: Process Development for the Spray-Drying of Probiotic Bacteria and Evaluation of the Product Quality
Published on: April 7, 2023
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.
Abstract:
Probiotics are effective in reducing necrotising enterocolitis in preterm infants, but routine use is not generally adopted. We describe a safety issue concerning contamination by pathogenic bacteria and missing of labelled strains in a probiotic product widely used in neonatal care. We recommend all centres using probiotics in the care of vulnerable patients to consider product safety checks in addition to the quality reports of manufacturers. Meanwhile, clinicians and manufacturers should collaborate to define quality standards for probiotic products in clinical settings as long as specific international regulations are lacking.
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