The objective of the study, conducted at the University of Tor Vergata (Rome, Italy), was to study the effectiveness of the symbiotic in reducing the frequency of the most common infections in winter in children.

In winter, a multicentre randomized, double-blind, placebo-controlled study was conducted in children aged 3 to 7 years. Study participants had at least three episodes of infections of the ENT organs, respiratory tract or gastrointestinal tract during the previous winter. Patients received a daily symbiotic (a preparation containing Lactobacillus helveticus R0052, Bifidobacterium infantis R0033, Bifidobacterium bifidum R0071 and fructooligosaccharides) or a placebo during 3 months. During the study period, all episodes of infections to be recorded were recorded in the patient diary by the parents of the patients. The logs were checked by the researchers every month when the patient and the parents visited the clinic. The primary outcome measure was the percentage of children who did not have a single episode of infectious disease during the entire study period.

During the study, 135 children were randomized (mean age 4.1 ± 1.0 year), of which 62 children received a symbiotic and 73 people received a placebo. At least one episode of the disease was recorded in 32 children in the symbiotic group and in 50 children in the placebo group (51.6% vs 68.5%, respectively), which reflects a risk of statistically significant reduction of 25% in the probability of developing an infection (95% confidence interval 0.6-44.3%, p = 0.045). This difference was due to a decrease in the number of children who had at least one episode of diseases of the ENT organs, respiratory tract or gastrointestinal tract (50% in the symbiotic group vs 67, 1% in the placebo group, p = 0.044). A jump to school (at least one day of class) was observed in 25.8% of children receiving a symbiotic, compared to 42.5% of patients in the placebo group (p = 0.043). None of the groups evaluated reported treatment-related adverse events.

Thus, the results of the study indicate that a 3-month preventive cycle of the symbiotic can reduce the risk of developing the most common diseases in children in winter.