Multi‐Strain Probiotic and Common Infections in Early Childhood Education Settings: A Randomised Controlled Trial

ABSTRACT Objective This randomised controlled trial aimed to evaluate the effect of a multi‐strain probiotic on the incidence of common infections among children in early childhood education (ECE) settings. Methods Prospective, randomised, double‐blind, placebo‐controlled trial was conducted using a multi‐strain (mixture of 5 strains) probiotic at a daily dose of 10 billion active fluorescent units. Participating children were randomly assigned to either the intervention or control group. The supplementation period lasted 24 weeks, during which weekly questionnaires were administered to track the incidence of infections. Results A total of 118 children were enrolled in the trial. An intention‐to‐treat analysis revealed a 62% reduction in the incidence of gastrointestinal tract infections (GITIs) (incidence rate ratio: 1. 62, p = 0. 055) between the placebo and probiotic groups in the last 16 weeks of the study. Notably, it took up to 8 weeks for probiotics to exhibit a significant protective effect. However, probiotic supplementation had no impact on respiratory tract infections (RTIs). Additionally, probiotic use led to an estimated cost saving of AU4748 in relation to reducing GITIs for 16 weeks after the protective effect was achieved. Conclusion Multi‐strain probiotic has the potential to reduce the risk of GITIs among children in ECE settings, though no beneficial effect was observed on RTIs despite recording over 450 infections. Larger, multi‐arm trials are recommended to further investigate this area. Trial Registration: ClinicalTrials. gov identifier: ACTRN12622000153718.