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

## TL;DR

A multi-strain probiotic reduced gastrointestinal infections in children at daycare, but had no effect on respiratory infections.

## Contribution

This is the first study to show that multi-strain probiotics may take about two months to show protective effects against infections in children.

## Key findings

- Probiotic use led to a 62% reduction in gastrointestinal tract infections after 16 weeks.
- The protective effect of probiotics took up to 8 weeks to become significant.
- Probiotic supplementation saved AU$4748 in infection-related costs over 4 months.

## Abstract

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.

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.

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 AU$4748 in relation to reducing GITIs for 16 weeks after the protective effect was achieved.

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.

Summary
What is already known on this topic○Early childhood education (ECE) attendance is associated with an increased risk of infections.○Probiotics have the potential to influence the immune system.
What this paper adds○In this study, multi‐strain probiotic reduced gastrointestinal tract infections (GITIs) among children in ECE settings. This is the first study to suggest that probiotics may require approximately 2 months to take effect.○Probiotic use saved AU$4748 in infection‐related costs within 4 months.

What is already known on this topic○Early childhood education (ECE) attendance is associated with an increased risk of infections.○Probiotics have the potential to influence the immune system.

Early childhood education (ECE) attendance is associated with an increased risk of infections.

Probiotics have the potential to influence the immune system.

What this paper adds○In this study, multi‐strain probiotic reduced gastrointestinal tract infections (GITIs) among children in ECE settings. This is the first study to suggest that probiotics may require approximately 2 months to take effect.○Probiotic use saved AU$4748 in infection‐related costs within 4 months.

In this study, multi‐strain probiotic reduced gastrointestinal tract infections (GITIs) among children in ECE settings. This is the first study to suggest that probiotics may require approximately 2 months to take effect.

Probiotic use saved AU$4748 in infection‐related costs within 4 months.