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J. Pediatr. Gastroenterol. Nutr. · Nov 2016
Randomized Controlled Trial Multicenter StudyFermented Milk Consumption and Common Infections in Children Attending Day-Care Centers: A Randomized Trial.
- Andrey Prodeus, Violeta Niborski, Juergen Schrezenmeir, Alexander Gorelov, Anna Shcherbina, and Alexander Rumyantsev.
- *Children's Clinical Hospital No. 9 named after G.N. Speransky of Moscow Healthcare Department, Moscow, Russia †Danone Nutricia Research, Centre de Recherche Daniel Carasso, Palaiseau, France ‡University Medicine, Johannes-Gutenberg-University, Mainz, Germany §Federal Budget Institution of Science "Central Research Institute of Epidemiology" of The Federal Service on Customers' Rights Protection and Human Well-being Surveillance ||Federal Government Budget Institution "Federal Scientific Clinical Center of Pediatric Hematology, Oncology and Immunology named after Dmitry Rogachev" of the Ministry of Health of Russian Federation, Moscow, Russia.
- J. Pediatr. Gastroenterol. Nutr. 2016 Nov 1; 63 (5): 534-543.
ObjectivesThis 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.MethodsChildren 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.ResultsThere 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.ConclusionsAlthough 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.
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