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

Probiotic supplementation resulted in a 62% reduction in gastrointestinal tract infections compared to placebo during the last 16 weeks of the study.

• Incidence rate ratio of 1.62 (p = 0.055) between placebo and probiotic groups
• The reduction was observed in the last 16 weeks of the 24-week supplementation period
• The trial was prospective, randomised, double-blind, and placebo-controlled
• 118 children were enrolled and analysis was conducted using intention-to-treat methodology

It took approximately 8 weeks for probiotics to exhibit a significant protective effect against gastrointestinal tract infections.

• The 24-week supplementation period was effectively divided into an initial 8-week period with no significant effect and a subsequent 16-week period with protective effect
• This delay suggests a lag period before probiotic colonisation or immune modulation reaches a protective threshold
• The multi-strain probiotic was administered at a daily dose of 10 billion active fluorescent units

Probiotic supplementation had no impact on respiratory tract infections (RTIs).

• No beneficial effect on RTIs was observed despite recording over 450 infections across the study
• This finding held across the full 24-week supplementation period
• The lack of effect on RTIs contrasts with the observed reduction in GITIs

Probiotic use was associated with an estimated cost saving of AU$4748 related to reducing GITIs over the 16-week protective period.

• Cost savings were calculated for the 16-week period after the protective effect was achieved
• Savings were attributed specifically to the reduction in gastrointestinal tract infections
• No cost analysis was reported for respiratory tract infections

The trial used a multi-strain probiotic consisting of a mixture of 5 strains administered daily over 24 weeks to children in early childhood education settings.

• Daily dose was 10 billion active fluorescent units
• 118 children were enrolled in total, randomly assigned to intervention or control groups
• Weekly questionnaires were administered throughout the 24-week supplementation period to track infection incidence
• The trial was registered with ClinicalTrials.gov identifier ACTRN12622000153718