The study to investigate the potential benefits of probiotics in yogurt, a patient-oriented, double-blind, cluster-randomised, placebo-controlled, clinical trial

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Background:Probiotic functional foods are widely advertised to consumers primarily based on probiotic supplements.Objective:Determine if consumption of yogurt containing a high dose of probiotics improves health in children ages 1–3 years attending daycare/school centers.Subjects/Methods:Double-blinded, randomized, placebo-controlled, allocation concealment clinical trial. Setting: Outpatient participants in the Washington, DC area. Participants: 182 healthy children between the age of 1 and 3 years attending daycare/ school at least 3 days a week. Intervention: Active was a strawberry yogurt-based drink supplemented with Bifidobacterium animalis ssp. lactis (B. lactis) BB-12. The placebo was indistinguishable from the active drink, differing only in absence of the probiotic BB-12. Primary objective was to determine if consumption of a probiotic-containing yogurt-based drink decreases absences due to illnesses from daycare for children ages 1–3 years. Secondary was to determine if probiotic-containing yogurt-based drink improves overall parental satisfaction due to decreased absences from work and an overall healthier child.Results:There were no significant differences in the days of missed school per group, with 51.9% in the active group and 47.1% in the placebo group missing at least 1 day of school throughout the study. Additionally, there were no differences in any secondary outcomes among the groups.Conclusions:Consumption of a yogurt-based drink delivering 1010 CFU of Bifidobacterium animalis ssp. lactis (B. lactis) BB-12 per day did not decrease the number of days missed of school due to an illness. Additional independent research on the potential of BB-12 to reduce illness in children needs to be conducted.

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