Preventive Effect of Cow’s Milk Fermented with Lactobacillus paracasei CBA L74 on Common Infectious Diseases in Children: A Multicenter Randomized Controlled Trial
What this study found
The fermented milk reduced common infectious diseases and was well tolerated, with no adverse events recorded. In intention-to-treat analysis, common infectious disease occurred in 60% of the active group versus 83% of controls (p < 0.01; ARD -23%, 95% CI -37% to -9%), and in per-protocol analysis 18% versus 40% (p < 0.01; ARD -22%, 95% CI -37% to -6%). Upper respiratory tract infection and acute gastroenteritis were also lower in the active group, and fewer children used at least one medication course (45% vs 65%); one child in the control group required hospitalization. The intervention…
- Study & population
- This was a multicenter randomized controlled trial in healthy children aged 12 to 48 months attending day care or preschool in urban Italy.
- Intervention
- Children in the active arm received 7 g/day of cow's skim milk fermented with Lactobacillus paracasei CBA L74 by mouth once daily for 3 months, diluted in up to 150 mL of cow's milk or water.
- Key limitation
- The trial had a relatively small sample size, and follow-up lasted only 3 months during a single winter season.
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Open PDFOriginal 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.