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Study Design

Type
Randomized Controlled Trial (RCT)
Population
94 healthy children; in a subgroup, 34 healthy, treated children
Methods
In a randomized study, tested a probiotic mixture containing Bifidobacterium animalis subspecies lactis BB-12 and Enterococcus faecium L3 on 94 healthy children, comparing the incidence and duration of episodes of AGE and the incidence of URTIs to those of a control group of 109 healthy, untreated subjects; in a subgroup consisting of 34 healthy, treated children, salivary IgA levels were also evaluated

Background

For healthy children, attending communities such as nurseries, kindergartens or schools, exposes them to the risk of acute gastroenteritis (AGE) and/or upper respiratory tract infections (URTIs). We therefore evaluated whether the use of a well-documented probiotic formula could act as prophylaxis for AGE and URTIs, reducing the risk of occurrence.

Methods

In a randomized study, we tested a probiotic mixture containing Bifidobacterium animalis subspecies lactis BB-12 and Enterococcus faecium L3 on 94 healthy children, comparing the incidence and duration of episodes of AGE and the incidence of URTIs to those of a control group of 109 healthy, untreated subjects. In a subgroup consisting of 34 healthy, treated children, we also evaluated salivary IgA levels.

Results

The use of the probiotic formula significantly reduced the incidence and duration of episodes of AGE by 82% and 45%, respectively, and the incidence and duration of episodes of URTIs by 84% and 50%. Salivary IgA levels significantly increased three-fold after 90 days of probiotic treatment. The probiotic formula was well tolerated and no side effects occurred.

Conclusions

According to our results, use of the probiotic strains BB-12 and L3 statistically reduced the risk of AGE and URTIs in healthy children and increased levels of salivary IgA.

Research Insights

SupplementDoseHealth OutcomeEffect TypeEffect SizeSource
Bifidobacterium animalis subsp. lactis BB-12Increased Salivary sIgA LevelsBeneficial
Moderate
View source

Salivary IgA levels significantly increased three-fold after 90 days of probiotic treatment.

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