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

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.

NCT Number	NCT07050693
Lead Sponsor	University of Bari
Conditions	Gastroenteric Tract, Respiratory Tract, Infections, Gastroenteric Infections
Enrollment	100 participants
Start Date	2025-04-17
Primary Completion	2025-09-01 (estimated)
Study Completion	2026-04-30 (estimated)
Updated on ClinicalTrials.gov	2025-07-09