Bifidobacterium animalis subsp. lactis in prevention of common infections in healthy children attending day care centers - Randomized, double blind, placebo-controlled study.

Abstract

Background & aims: The aim of our study was to investigate the role of Bifidobacterium animalis subsp. lactis (BB-12(®)) in the prevention of common (gastrointestinal and respiratory) infections in healthy children who attend day care centers.

Methods: We conducted a randomized, double-blind, placebo-controlled trial in 210 children who attend day care centers. They were randomly allocated to receive placebo (Placebo group, n = 106) or BB-12(®) at a dose of 10(9) colony-forming units (CFU) (Intervention group, n = 104) during the 3-month intervention period.

Results: Intention to treat analysis was used. There were overall 99 infections in Placebo group and 97 in Intervention group (incidence rate ratio = 1.0014, p = 0.992, Poisson regression model). Overall 65 children (61.3%) in Placebo group and 67 (64.4%) in Intervention group had common infections (p = 0.642). Mean number of infections per child was 0.93 (range 0-3) in Placebo group and 0.93 (range 0-3) in Intervention group (p = 0.898). There was no difference in secondary (duration of symptoms, number of children with gastrointestinal and respiratory tract infections, absence from day care center due to infections, use of antibiotics) and exploratory (type of gastrointestinal and respiratory tract infection) endpoints between groups.

Conclusion: Results of performed study show that BB-12(®) has no effect on the prevention of gastrointestinal and respiratory tract infections in healthy children who attend day care centers.

Trial registration: ClinicalTrials.gov NCT01702753.

Keywords: BB-12(®); Children; Infection; Prevention; Probiotics.