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

Sponsor
University of Bari
Study ID
NCT07050693
Status
Recruiting
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Conditions

  • Gastroenteric Infections
  • Gastroenteric Tract
  • Infections
  • Respiratory Tract

Eligibility Criteria

Sex
ALL
Age
12 Months - 48 Months
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Jul 3, 2025
Start date
Apr 17, 2025
Status verified
Jun 2025
Primary completion
Sep 1, 2025
Completion
Apr 30, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Experimental
    50 children will take the product under study based on Vitamin D, Zinc, Beta glucan, 2'Fucosyllactose
  • Placebo Comparator: Placebo
    50 children will take a carbohydrate-based control product (maltodextrin)

Primary Outcome Measure

Primary outcome [ Time Frame: The dietary supplement and placebo will be administered for three months from the date of enrollment. ]

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