Fermented Milk Consumption and Common Infections in Children Attending Day-Care Centers: A Randomized Trial

Abstract

Objectives: This multicenter, double-blind, randomized, placebo-controlled clinical trial investigated the effect of a fermented milk product containing the Lactobacillus casei National Collection of Microorganisms and Cell Cultures (CNCM) I-1518 strain on respiratory and gastrointestinal common infectious diseases (CIDs) in children attending day-care centers in Russia.

Methods: Children ages 3 to 6 years received 100 g of a fermented milk product (n = 300) or a control product (n = 299) twice daily for 3 months, followed by a 1-month observation period. The primary outcome was the incidence of CIDs during the product consumption period.

Results: There was no significant difference in the incidence of CIDs between the groups (N = 98 with fermented milk product vs N = 93 with control product). The overall number of CIDs (and no severe cases at all) in both study groups and in all 12 centers, however, was unexpectedly low resulting in underpowering of the study. No differences were found between the groups in the duration or severity of disease, duration of sick leave from day-care centers, parental missed working days, or in quality-of-life dimensions on the PedsQL questionnaire (P > 0.05).There was, however, a significantly lower incidence of the most frequently observed CID, rhinopharyngitis, in children consuming the fermented milk product compared with those consuming the control product (N = 81 vs N = 100, relative risk 0.82, 95% confidence interval 0.69-0.96, P = 0.017) when considering the entire study period.

Conclusions: Although no other significant differences were shown between the fermented milk and control product groups in this study, lower incidence of rhinopharyngitis may indicate a beneficial effect of this fermented milk product.

Trial registration: ClinicalTrials.gov NCT01200173.

FIGURE 1

Design of the study. D = day; M = month; OTC = over the counter; QoL = Quality of life questionnaire; V = visit; W = week.

FIGURE 2

Absolute number of cases with rhinopharyngitis experienced during different study periods in which the active (fermented milk) product group is indicated by diagonal lines. Statistically significant difference between active and control, as indicated, was found in the number of rhinopharyngitis cases (these being the major part of CIDs observed) during the total study period (including 3 months of products consumption period and 1 month of follow-up). CID = common infectious disease.