OBJECTIVES: The risk of infections is higher in children attending child care compared with children cared for at home. This study examined the effect of a combination of probiotics on absence from child care because of respiratory and gastrointestinal infections in healthy infants aged 8 to 14 months at the time of enrollment in child care.

METHODS: The ProbiComp study was a randomized, double-blind, placebo-controlled study. A total of 290 infants were randomly allocated to receive a placebo or a combination of Bifidobacterium animalis subsp lactis and Lactobacillus rhamnosus in a dose of 10(9) colony-forming units of each daily for a 6-month intervention period. Absence from child care, occurrence of infant symptoms of illness, and doctor visits were registered by the parents using daily and weekly Web-based questionnaires.

RESULTS: Median absence from child care was 11 days (interquartile range: 6-16). Intention-to-treat analysis showed no difference between the probiotics and placebo groups (P = .19). Additionally, there was no difference in any of the secondary outcomes between groups; the number of children with doctor-diagnosed upper or lower respiratory tract infections, the number of doctor visits, antibiotic treatments, occurrence and duration of diarrhea, and days with common cold symptoms, fever, vomiting, or caregivers' absence from work.

CONCLUSIONS: A daily administration of a combination of B animalis subsp lactis and L rhamnosus for 6 months did not reduce the number of days absent from child care in healthy infants at the time of enrollment in child care.