Efficacy of a 2'-Fucosylactose-based Food Supplement on the Prevention of Respiratory and Gastrointestinal Infections.

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-48
SponsorUniversity of Bari

About this trial

Respiratory and gastrointestinal infections are frequent problems in children under 4 years of age, especially after the start of schooling. These conditions are facilitated by an incomplete maturation of the immune system and by the anatomical and functional structure of the respiratory and gastrointestinal tract still in development.

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, sometimes with conflicting results. Some scientific evidence has shown that the administration of Vitamin D, Zinc, Beta glucan, 2'-Fucosyllactose can stimulate the immune defenses and reduce the number and severity of infectious episodes. In particular, 2'-fucosyllactose is one of the oligosaccharides of breast milk. It has both a prebiotic and immunoregulatory action since it is able to prevent the adhesion of pathogens to epithelial surfaces and subsequent translocation.

Healthy school-going children aged between 12 and 48 months, who attend school at least 5 days a week, will be evaluated.

Eligibility criteria

Qualifiers

Healthy school-going children aged 12 to 48 months who attend school at least 5 days a week

Disqualifiers

Age less than 12 months and more than 48 months;

Concomitant presence of chronic diseases

Congenital heart disease;

Tuberculosis;

Trial design

Treatments tested in this trial

  • Vitamin + Zinc + micronutrient mixture
  • Placebo

Treatment groups

100 Participants
are divided into 2 treatment groups

Sponsors and collaborators