An interventional study of Vitamin + Zinc + micronutrient mixture and Placebo in Gastroenteric Tract, Respiratory Tract and Infections, sponsored by University of Bari. Recruiting at 1 site in Italy. Open to participants aged 12 Months to 48 Months. Per ClinicalTrials.gov, last updated 2025-07-09.
Sponsored by University of Bari · Not applicable, Interventional, and Prevention
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.
2,093 studies on the registry are indexed under Infections; 364 are open to participants now.
This study's planned enrollment of 100 is below the median of 113 across 1,304 interventional studies indexed under Infections.
Browse Infections studies →University of Bari is the lead sponsor of 76 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
50 children will take the product under study based on Vitamin D, Zinc, Beta glucan, 2'Fucosyllactose
Dietary Supplement: Vitamin + Zinc + micronutrient mixture
50 children will take a carbohydrate-based control product (maltodextrin)
Dietary Supplement: Placebo
a dietary supplement containing Vitamin D, Zinc, Beta glucan WELLMUNE WGP, 2'Fucosyllactose.
Also known as: Experimental arm
Placebo is identical to intervention product
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.
Plan to share: Undecided
Started Apr 2025 (actual). Primary completion is estimated for Sep 2025, 4 months after the start.
Of 274 non-industry interventional studies with no phase under Infections, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 51. This study's planned 4 months is below that.
Counting every sponsor, half of 305 studies reached it within 24 months; a quarter within 10 and three quarters within 50.
Infections covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
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University of Bari