2'-Fucosyllactose-based supplement to prevent respiratory and gut infections in young children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Pediatria Trambusti
  Bari, Bari, Italy Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.