Preventive effect of cow’s milk fermented with lactobacillus paracasei CBA L74 on common infectious diseases in children

A multicenter randomized controlled trial

Giovanni Corsello, Maurizio Carta, Roberto Marinello, Marina Picca, Giulio De Marco, Maria Micillo, Dante Ferrara, Patrizia Vigneri, Gaetano Cecere, Pasqualina Ferri, Paola Roggero, Giorgio Bedogni, Fabio Mosca, Lorella Paparo, Rita Nocerino, Roberto Berni Canani

Research output: Contribution to journalArticle

6 Citations (Scopus)

Abstract

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.

Original languageEnglish
Article number669
JournalNutrients
Volume9
Issue number7
DOIs
Publication statusPublished - Jul 1 2017

Fingerprint

Lactobacillus paracasei
infectious diseases
Communicable Diseases
Milk
Randomized Controlled Trials
milk
skim milk
child care
gastroenteritis
Gastroenteritis
Adaptive Immunity
Child Care
Dietary Supplements
Innate Immunity
cows
placebos
dietary supplements
biomarkers
Biomarkers
Placebos

Keywords

  • Acquired immunity
  • Acute gastroenteritis
  • Gut microbiota
  • Immunonutrition
  • Innate immunity
  • Probiotics
  • Upper respiratory tract infections

ASJC Scopus subject areas

  • Food Science

Cite this

Preventive effect of cow’s milk fermented with lactobacillus paracasei CBA L74 on common infectious diseases in children : A multicenter randomized controlled trial. / Corsello, Giovanni; Carta, Maurizio; Marinello, Roberto; Picca, Marina; De Marco, Giulio; Micillo, Maria; Ferrara, Dante; Vigneri, Patrizia; Cecere, Gaetano; Ferri, Pasqualina; Roggero, Paola; Bedogni, Giorgio; Mosca, Fabio; Paparo, Lorella; Nocerino, Rita; Canani, Roberto Berni.

In: Nutrients, Vol. 9, No. 7, 669, 01.07.2017.

Research output: Contribution to journalArticle

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 & Canani, RB 2017, 'Preventive effect of cow’s milk fermented with lactobacillus paracasei CBA L74 on common infectious diseases in children: A multicenter randomized controlled trial', Nutrients, vol. 9, no. 7, 669. https://doi.org/10.3390/nu9070669
Corsello, Giovanni ; Carta, Maurizio ; Marinello, Roberto ; Picca, Marina ; De Marco, Giulio ; Micillo, Maria ; Ferrara, Dante ; Vigneri, Patrizia ; Cecere, Gaetano ; Ferri, Pasqualina ; Roggero, Paola ; Bedogni, Giorgio ; Mosca, Fabio ; Paparo, Lorella ; Nocerino, Rita ; Canani, Roberto Berni. / Preventive effect of cow’s milk fermented with lactobacillus paracasei CBA L74 on common infectious diseases in children : A multicenter randomized controlled trial. In: Nutrients. 2017 ; Vol. 9, No. 7.
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abstract = "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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author = "Giovanni Corsello and Maurizio Carta and Roberto Marinello and Marina Picca and {De Marco}, Giulio and Maria Micillo and Dante Ferrara and Patrizia Vigneri and Gaetano Cecere and Pasqualina Ferri and Paola Roggero and Giorgio Bedogni and Fabio Mosca and Lorella Paparo and Rita Nocerino and Canani, {Roberto Berni}",
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T1 - Preventive effect of cow’s milk fermented with lactobacillus paracasei CBA L74 on common infectious diseases in children

T2 - A multicenter randomized controlled trial

AU - Corsello, Giovanni

AU - Carta, Maurizio

AU - Marinello, Roberto

AU - Picca, Marina

AU - De Marco, Giulio

AU - Micillo, Maria

AU - Ferrara, Dante

AU - Vigneri, Patrizia

AU - Cecere, Gaetano

AU - Ferri, Pasqualina

AU - Roggero, Paola

AU - Bedogni, Giorgio

AU - Mosca, Fabio

AU - Paparo, Lorella

AU - Nocerino, Rita

AU - Canani, Roberto Berni

PY - 2017/7/1

Y1 - 2017/7/1

N2 - 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.

AB - 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.

KW - Acquired immunity

KW - Acute gastroenteritis

KW - Gut microbiota

KW - Immunonutrition

KW - Innate immunity

KW - Probiotics

KW - Upper respiratory tract infections

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