Fermented Milk on the Appearance of Common Winter Infectious Diseases
Condition: Acute Gastroenteritis; Upper Respiratory Tract Infections
MeSH terms: Communicable Diseases; Infections; Respiratory Tract Infections; Gastroenteritis
Study type: Interventional
Phase: Phase 2

Summary: 
      Respiratory and gastrointestinal infections are common in children under the age of 4 years,
      especially after the start of schooling. These conditions are facilitated by a still
      incomplete functional maturation of the immune system and the anatomical structure and
      function of the respiratory and gastrointestinal tract still developing. The frequency and
      duration of these conditions involves a high discomfort and significant costs, in relation to
      medical appointments, taking medication, the need for hospitalization, days of absence from
      school and work days lost by parents. Functional foods derived from the fermentation of cow's
      milk with probiotic strains have been proposed for the prevention of infectious diseases in
      children. Several products have been investigated, with sometimes conflicting results.
      Diversity in experimental designs, populations evaluated, and bacterial strains used in the
      preparation of fermented products are probably responsible for these discrepancies. Recently
      we started a study approved by the Ethics Committee for Biomedical Activities "Carlo Romano"
      of the University of Naples "Federico II" (protocol number 210/12) to evaluate the
      effectiveness of foods fermented with Lactobacillus paracasei CBA-L74 in the prevention of
      common winter infections in school children aged between 12 and 48 months. Studies of
      pre-clinical phase showed anti-inflammatory activity of milk fermented with the strain
      Lactobacillus paracasei L74-CBA in terms of stimulation of the production of the cytokine
      IL-10 and decreased synthesis of IL-12, also in response to stimulation with Salmonella
      typhimurium. The data were obtained in in vitro studies on dendritic cells and ex vivo
      intestinal biopsies as well as in tests on healthy mice and on a mouse model of experimental
      colitis. A preliminary analysis of the data was found that subjects treated with fermented
      milk showed fewer infectious episodes, as well as a lower incidence of respiratory tract
      infections or gastrointestinal, with a statistically significant difference between the study
      groups. It was also observed a significant increase in the levels of α- and β- defensins,
      LL-37 and secretory IgA in the group of subjects treated with fermented milk compared to
      subjects treated with fermented rice or placebo.

      Therefore, we decided to extend the period of study of five additional months, in order to
      perform an evaluation of the effectiveness of fermented milk (which was more effective)vs
      placebo.
    


Intervention name(s): Fermented milk; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Fermented milk with Lactobacillus paracasei CBA L74; Maltodextrin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention