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

NCT07050693 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-07-09

No results posted yet for this study

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

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

Sponsors & Collaborators

  • University of Bari

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
12 Months
Max Age
48 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-17
Primary Completion
2025-09-01
Completion
2026-04-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07050693 on ClinicalTrials.gov