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Updated: Jun 8, 2026

Probiotic Studies in Neonatal Mice Using Gavage
Published on: January 27, 2019
Should the use of probiotics in the preterm be routine?
Michael Millar1, Mark Wilks, Paul Fleming
1Department of Infection, Barts and The London NHS Trust, 80 Newark St, Whitechapel, London, UK. m.r.millar@qmul.ac.uk
Insights
Clinical trials do not yet justify routine probiotic use in preterm infants due to uncertainties in efficacy, safety, and long-term outcomes. A precautionary approach is recommended before widespread adoption in neonatal care.
Area of Science:
- Neonatal Medicine
- Microbiology
- Clinical Trials
Background:
- Probiotics are increasingly considered for preterm infants.
- Significant uncertainties exist regarding their efficacy and safety.
- Mechanisms of action and optimal administration remain unclear.
Purpose of the Study:
- To evaluate if current clinical evidence supports routine probiotic use in preterm infants.
- To highlight knowledge gaps concerning probiotic benefits and risks.
- To advocate for a cautious approach to introducing probiotics in neonatal practice.
Main Methods:
- Review of clinical trial evidence on probiotic interventions in preterm neonates.
- Analysis of uncertainties related to probiotic mechanisms, efficacy, and safety.
- Consideration of ecological and long-term health consequences.
Main Results:
- Current evidence is insufficient to justify routine probiotic use.
- Significant gaps exist in understanding who benefits and potential harms.
- Lack of defined probiotic products with established safety profiles.
Conclusions:
- A precautionary principle should guide the introduction of probiotics.
- Further research is needed to clarify efficacy, safety, and ecological impacts.
- Monitoring of microbiological, ecological, and long-term outcomes is crucial before routine use.
Abstract:
Does the clinical trials' evidence of benefit justify the routine use of probiotics in the preterm infant? There are many uncertainties surrounding the use of probiotics in the preterm, including the mechanism(s) of action of probiotics, knowledge of who benefits and who might not, whether it is placement of large numbers of bacteria into the small intestine or colonisation that determines efficacy, the forms of microbial adaptation(s) and ecological consequences. There is also a current lack of defined products with associated evidence of safety in the preterm infant. It is argued that one cannot assume safety because of a lack of evidence of harm and that one should take a precautionary approach to the introduction of probiotics into routine neonatal practice. One should also consider how best one might monitor microbiological and ecological consequences and longer-term health outcomes before the introduction of this novel intervention into routine practice.
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