Multi-Strain Probiotic and Common Infections in Early Childhood Education Settings: A Randomised Controlled Trial.
- 2026-01-23
- Journal of paediatrics and child health 62(3)
- Hafiz Haris Ahmad
- Blake Peck
- Daniel Terry
- PubMed: 41574644
- DOI: 10.1111/jpc.70295
Study Design
- Type
- Randomized Controlled Trial (RCT)
- Sample size
- n = 118
- Population
- children in early childhood education (ECE) settings
- Methods
- Prospective, randomised, double-blind, placebo-controlled trial using a multi-strain (mixture of 5 strains) probiotic at a daily dose of 10 billion active fluorescent units; supplementation period lasted 24 weeks with weekly questionnaires to track the incidence of infections.
- Large Human Trial
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 AU$4748 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.Research Insights
- Bifidobacterium animalis subsp. lactis BB-12→No Significant Reduction in Lower Respiratory Tract Infections
probiotic supplementation had no impact on respiratory tract infections (RTIs).
- Effect
- Neutral
- Effect size
- Small
An intention-to-treat analysis revealed a 62% reduction in the incidence of gastrointestinal tract infections (GITIs) ... in the last 16 weeks of the study. Notably, it took up to 8 weeks for probiotics to exhibit a significant protective effect.
- Effect
- Beneficial
- Effect size
- Moderate
However, probiotic supplementation had no impact on respiratory tract infections (RTIs).
- Effect
- Neutral
- Effect size
- Small
probiotic supplementation had no impact on respiratory tract infections (RTIs).
- Effect
- Neutral
- Effect size
- Small
An intention-to-treat analysis revealed a 62% reduction in the incidence of gastrointestinal tract infections (GITIs) ... in the last 16 weeks of the study. Notably, it took up to 8 weeks for probiotics to exhibit a significant protective effect.
- Effect
- Beneficial
- Effect size
- Moderate
probiotic supplementation had no impact on respiratory tract infections (RTIs).
- Effect
- Neutral
- Effect size
- Small
An intention-to-treat analysis revealed a 62% reduction in the incidence of gastrointestinal tract infections (GITIs) ... in the last 16 weeks of the study. Notably, it took up to 8 weeks for probiotics to exhibit a significant protective effect.
- Effect
- Beneficial
- Effect size
- Moderate