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

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.

Nutrimune and immune defence against pathogens in the gastrointestinal and upper respiratory tracts: evaluation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006

“…b) Centre was found to be a significant confounder related to the low power in the Milan and Palermo centres in the study by Corsello et al (2017). b) Centre was found to be a significant confounder related to the low power in the Milan and Palermo centres in the study by Corsello et al (2017).…”

“…The post hoc statistical re-analysis (Calame, 2018, unpublished) consists of a combined analysis with data from one study and data from each centre (n = 3) participating in the second study (Corsello et al, 2017). According to the applicant, the combined analysis aimed to: (a) increase the power of the studies by assigning a positive event to the drop-outs, and (b) identify potential heterogeneity between the two studies in order to address the multicentre approach in the study by Corsello et al (2017).…”

“…The Panel notes that centre was found to be a significant confounder for the effect of Nutrimune on the incidence of infections, and that this effect was attributed to the Milan and Palermo centres in the study by Corsello et al (2017). The Panel also notes that tests for heterogeneity involving a small number of studies (or centres) are likely to be underpowered, and therefore non-significant p values are not necessarily a proof of non-heterogeneity.…”

Functional nutrients in infants born by vaginal delivery or Cesarean section

“…40 However, a recent multicenter, randomized, double-blind, placebo-controlled study revealed that the administration of fermented skim milk with Lactobacillus paracasei CBA L74 could prevent common respiratory and intestinal infections in preschool-age children (12-48 months of life). 41 Further research is needed to demonstrate the capacity of this fermented matrix to modify the neonatal microbiota, but the available data would seem to confirm its role. 42 In addition to maternal or neonatal supplementation with these functional nutrients, other methods have also been experimented to achieve effective microbiota modification.…”

Influence of Mixing Peanut Milk and Honey with Cow Milk on the Nutritional and Health Properties of Bio- Rayeb Milk

“…Research evidence for numerous probiotic benefits such as obesity-related disorders, antibioticassociated diarrhea, infections, and cancer was described [3]. Corsello et al [4] stated that dietary supplementation with cow's skim milk fermented with Lactobacillus paracasei CBA L74 is an efficient strategy in preventing common infectious diseases in children.…”