Preventive Effect of Cow’s Milk Fermented with Lactobacillus paracasei CBA L74 on Common Infectious Diseases in Children: A Multicenter Randomized Controlled Trial
by
Giovanni Corsello 1, Maurizio Carta 1, Roberto Marinello 2, Marina Picca 3, Giulio De Marco 4, Maria Micillo 4, Dante Ferrara 5, Patrizia Vigneri 6, Gaetano Cecere 4, Pasqualina Ferri 4, Paola Roggero 7, Giorgio Bedogni 8, Fabio Mosca 7, Lorella Paparo 4, Rita Nocerino 4 and Roberto Berni Canani 4,9,10,*
Giovanni Corsello 1, Maurizio Carta 1, Roberto Marinello 2, Marina Picca 3, Giulio De Marco 4, Maria Micillo 4, Dante Ferrara 5, Patrizia Vigneri 6, Gaetano Cecere 4, Pasqualina Ferri 4, Paola Roggero 7, Giorgio Bedogni 8, Fabio Mosca 7, Lorella Paparo 4, Rita Nocerino 4 and Roberto Berni Canani 4,9,10,*
1
Operative Unit of Pediatrics and Neonatal Intensive Therapy, Mother and Child Department, University of Palermo, 90121 Palermo, Italy
2
Federazione Italiana Medici Pediatri Lombardia, 46100 Mantova, Italy
3
Pediatric Society of Primary Health Care (SICuPP), 20135 Milan, Italy
4
Department of Translational Medical Science—Pediatric Section, University of Naples “Federico II” Via S. Pansini, 5, 80131 Naples, Italy
5
Department of Sciences for Health Promotion and Mother and Child Care, University of Palermo, 90121 Palermo, Italy
6
Family Pediatrician, 90133 Palermo, Italy
7
Department of Clinical Science and Community Health, Neonatal Intensive Care Unit, Fondazione I.R.C.C.S. Cà Granda Ospedale Maggiore Policlinico, University of Milan, 20143 Milan, Italy
8
Clinical Epidemiology Unit, Liver Research Center, Basovizza, 34012 Trieste, Italy
9
European Laboratory for the Investigation of Food-Induced Diseases, University of Naples “Federico II”, 80131 Naples, Italy
10
CEINGE Advanced Biotechnologies, University of Naples “Federico II”, 80131 Naples, Italy
*
Author to whom correspondence should be addressed.
Nutrients 2017, 9(7), 669; https://doi.org/10.3390/nu9070669
Received: 17 May 2017 / Revised: 16 June 2017 / Accepted: 21 June 2017 / Published: 27 June 2017
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 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.
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Keywords:
acute gastroenteritis; upper respiratory tract infections; probiotics; innate immunity; acquired immunity; gut microbiota; immunonutrition
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MDPI and ACS Style
Corsello, G.; Carta, M.; Marinello, R.; Picca, M.; De Marco, G.; Micillo, M.; Ferrara, D.; Vigneri, P.; Cecere, G.; Ferri, P.; Roggero, P.; Bedogni, G.; Mosca, F.; Paparo, L.; Nocerino, R.; Berni Canani, R. Preventive Effect of Cow’s Milk Fermented with Lactobacillus paracasei CBA L74 on Common Infectious Diseases in Children: A Multicenter Randomized Controlled Trial. Nutrients 2017, 9, 669.
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