Preventive Effect of Cow’s Milk Fermented with Lactobacillus paracasei CBA L74 on Common Infectious Diseases in Children: A Multicenter Randomized Controlled Trial

Nutrients

Jun 2017

DOI: 10.3390/nu9070669

Citations:77

Influential Citations:7

Interventional (Human) Studies

Enhanced Details

Methods

Multicenter, randomized, double-blind, placebo-controlled trial in healthy children aged 12-48 months attending day care or preschool (at least 5 days per week). 146 randomized (73 per group); 126 completed (66 in group A; 60 in group B); 71 males (56%).

Intervention

7 g/day of cow's skim milk powder fermented with Lactobacillus paracasei CBA L74 for 3 months, diluted in up to 150 mL cow's milk or water.

Results

Intention-to-treat: at least one CID occurred in 60% of group A vs 83% of group B (ARD -23%; 95% CI -37 to -9%; p<0.01). NNT = 4 (95% CI 3-11). Per-protocol: AGE 18% vs 40% (-22%; p<0.01); URTI 51% vs 74% (-23%; p<0.01); CID incidence rate ratio 0.64 (95% CI 0.42-0.98). Mean CID counts: 1.8 (A) vs 2.8 (B). Medication use: 45% vs 65% (-20%; p<0.05). Lost school days: IRR 0.26; mean 2 vs 8 days. Lost parental work days: IRR 0.18; mean 0.6 vs 3.3 days. Fecal markers of innate and acquired immunity (alpha- and beta-defensins, cathelicidin LL-37, and secretory IgA) increased at 3 months in group A. No adverse events; good compliance. Conclusion: Dietary supplementation with cow's skim milk fermented with L. paracasei CBA L74 reduces CIDs in young children attending daycare/preschool during winter, with lower infection burden, reduced medication use, fewer days lost from school/work, and enhanced mucosal immunity; findings are specific to this product/strain/dose/population and should not be generalized to other fermented products or strains.

Limitations

Inability to determine infection etiologies; lack of respiratory tract immunological biomarker assessment; single probiotic product/strain; short-term, winter-season study; limited generalizability to other strains or populations.

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. show less