2'-Fucosyllactose-based supplement to prevent respiratory and gut infections in young children
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.
This will test if a daily 2'-fucosyllactose-based vitamin and zinc supplement can reduce the number and severity of respiratory and gastrointestinal infections in children aged 12–48 months who attend school.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 12 Months to 48 Months |
| Sex | All |
| Sponsor | University of Bari Academic / other |
| Locations | 1 site (Bari, Bari) |
| Trial ID | NCT07050693 on ClinicalTrials.gov |
What this trial studies
Healthy children aged 12 to 48 months who attend school at least five days a week will receive either a 2'-fucosyllactose-based supplement containing vitamins, zinc and other micronutrients or a matching placebo. The supplement is intended to act as a prebiotic and immunomodulatory agent to reduce pathogen adhesion to epithelial surfaces and support immune defenses, with outcomes focused on infection frequency and severity. Key exclusions include chronic diseases, immunodeficiencies, recent antibiotic or pre/pro/symbiotic use, ongoing breastfeeding, severe malnutrition, and select gastrointestinal or respiratory conditions. The intervention is delivered at a single pediatric center in Bari, Italy, with follow-up to capture infectious episodes and related health impacts.
Who should consider this trial
Good fit: Ideal candidates are otherwise healthy, non-breastfeeding children aged 12–48 months who attend school at least five days per week and have no chronic or immunologic conditions.
Not a fit: Children with chronic illnesses, immunodeficiencies, recent antibiotic or pre/pro/symbiotic use, ongoing breastfeeding, severe malnutrition, or those outside the 12–48 month age range are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If effective, the supplement could lower infection episodes and symptoms in young children, reducing doctor visits and missed school days.
How similar studies have performed: Some clinical and mechanistic studies support immunomodulatory and anti-adhesive effects of 2'-fucosyllactose and micronutrients like vitamin D and zinc, but pediatric clinical results have been mixed.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Healthy school-going children aged 12 to 48 months who attend school at least 5 days a week Exclusion Criteria: * Age less than 12 months and more than 48 months; * Concomitant presence of chronic diseases * Congenital heart disease; * Tuberculosis; * Functional gastrointestinal disorders; * Gastrointestinal or urinary surgery of the respiratory tract; * Autoimmune diseases; * Immunodeficiencies; * Chronic inflammatory bowel diseases; * Celiac disease; * Cystic fibrosis; * Metabolic diseases; * Lactose intolerance; * Tumors; * Chronic lung diseases and malformations of the gastrointestinal tract; * Food allergies; * Eosinophilic esophagitis; * Other hypereosinophilic diseases of the gastrointestinal tract; * Diarrhea at enrollment; * Severe malnutrition (z score for weight/height less than 3SD); * Taking antibiotics and/or pre/pro/symbiotics/immunostimulants within 2 weeks of starting the study; * Breastfeeding in progress
Where this trial is running
Bari, Bari
- Pediatria Trambusti — Bari, Bari, Italy (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.