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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Competing interests The authors are currently involved in a randomised placebo-controlled trial of a probiotic in preterm infants.
Provenance and peer review Commissioned; externally peer reviewed.