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RESEARCH PRODUCT
Preventive Effect of Cow's Milk Fermented with Lactobacillus paracasei CBA L74 on Common Infectious Diseases in Children: A Multicenter Randomized Controlled Trial
Rita NocerinoMaria MicilloMarina PiccaMaurizio CartaPasqualina FerriRoberto Berni CananiDante FerraraGaetano CecerePatrizia VigneriGiorgio BedogniFabio MoscaRoberto MarinelloPaola RoggeroLorella PaparoGiulio De MarcoGiovanni Corsellosubject
0301 basic medicineMalePediatricsCultured Milk ProductsGroup Blaw.inventionDefensinsFeces0302 clinical medicineRandomized controlled triallawOtitisacute gastroenteritisinnate immunityRhinitisNutrition and DieteticsbiologyAbsolute risk reductionfood and beveragesPharyngitisLacticaseibacillus paracaseiGastroenteritisMilkChild Preschool030211 gastroenterology & hepatologyFemaleTracheitisprobioticacute gastroenteritimedicine.medical_specialtyLactobacillus paracaseiPlaceboCommunicable DiseasesArticle03 medical and health sciencesDouble-Blind MethodCathelicidinsInternal medicinemedicineAnimalsHumansimmunonutritionFecesIntention-to-treat analysisgut microbiotabusiness.industryProbioticsInfantacute gastroenteritis; upper respiratory tract infections; probiotics; innate immunity; acquired immunity; gut microbiota; immunonutritionupper respiratory tract infectionsbiology.organism_classificationmedicine.diseaseImmunoglobulin Aacquired immunity030104 developmental biologyUpper respiratory tract infectionupper respiratory tract infectionSample SizeFermentationCattlebusinessFood ScienceAntimicrobial Cationic Peptidesdescription
Background: Fermented foods have been proposed to prevent common infectious diseases (CIDs) in children attending day care or preschool. Objectives: To investigate the efficacy of dietary supplementation with cow’s skim milk fermented with the probiotic Lactobacillus paracasei CBA L74 in reducing CIDs in children attending day care or preschool. Methods: Multicenter, randomized, double-blind, placebo-controlled trial on healthy children (aged 12–48 months) consuming daily 7 grams of cow’s skim milk fermented with L. paracasei CBA L74 (group A), or placebo (maltodextrins group B) attending day care or preschool during the winter season. The main outcome was the proportion of children who experienced ≥1 episode of CID during a 3-month follow-up. Fecal biomarkers of innate (α- and β-defensins, cathelicidin) and acquired immunity (secretory IgA) were also monitored. Results: A total of 126 children (71 males, 56%) with a mean (SD) age of 33 (9) months completed the study, 66 in group A and 60 in group B. At intention to treat analysis, the proportion of children presenting ≥1 CID was 60% in group A vs. 83% in group B, corresponding to an absolute risk difference (ARD) of −23% (95% CI: −37% to −9%, p < 0.01). At per-protocol-analysis (PPA), the proportion of children presenting ≥1 CID was 18% in group A vs. 40% in group B, corresponding to an absolute risk difference (ARD) of −22% (95% CI: −37% to −6%, p < 0.01). PPA showed that the proportion of children presenting ≥1 acute gastroenteritis (AGE) was significantly lower in group A (18% vs. 40%, p < 0.05). The ARD for the occurrence of ≥1 AGE was −22% (95% CI: −37% to −6%, p < 0.01) in group A. Similar findings were obtained at PPA regarding the proportion of Nutrients 2017, 9, 669; doi:10.3390/nu9070669 www.mdpi.com/journal/nutrients Nutrients 2017, 9, 669 2 of 15 children presenting ≥1 upper respiratory tract infection (URTI), which was significantly lower in group A (51% vs. 74%, p < 0.05), corresponding to an ARD of −23% (95% CI: −40% to −7%, p < 0.01). Significant changes in innate and acquired immunity biomarkers were observed only in subjects in group A. Conclusions: Dietary supplementation with cow’s skim milk fermented with L. paracasei CBA L74 is an efficient strategy in preventing CIDs in children.
| year | journal | country | edition | language |
|---|---|---|---|---|
| 2017-06-27 |