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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Vitamin + Zinc + micronutrient mixture
Dietary supplementa dietary supplement containing Vitamin D, Zinc, Beta glucan WELLMUNE WGP, 2'Fucosyllactose.
Placebo
Dietary supplementPlacebo is identical to intervention product
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: ExperimentalExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Primary outcome
The primary aim of the study will be the percentage of children who will present at least one infectious episode (acute gastroenteritis, rhinitis, otitis, pharyngitis, laryngitis, tracheitis) diagnosed by the pediatrician during the 3-month study period.
Time frame
The dietary supplement and placebo will be administered for three months from the date of enrollment.Sponsors and contacts
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Source ClinicalTrials.gov