NCT07050693

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

Efficacy of A 2'-Fucosylactose-based Food Supplement on the Prevention of Respiratory and Gastrointestinal Infections in Schhol-attended Children: a Randomized, Double-blind, Placebo-controlled Trial.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University of Bari · Academic / Other
• Sex: All
• Age: 12 Months – 48 Months
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Gastroenteric Tract
• Respiratory Tract
• Infections
• Gastroenteric Infections

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Vitamin + Zinc + micronutrient mixture	a dietary supplement containing Vitamin D, Zinc, Beta glucan WELLMUNE WGP, 2'Fucosyllactose.
DIETARY_SUPPLEMENT	Placebo	Placebo is identical to intervention product

Timeline

• Start date: 2025-04-17
• Primary completion: 2025-09-01
• Completion: 2026-04-30
• First posted: 2025-07-03
• Last updated: 2025-07-09

Locations

1 site across 1 country: Italy