Efficacy of a 2'-Fucosylactose-based Food Supplement on the Prevention of Respiratory and Gastrointestinal Infections.
Recruiting now · Not applicable · Has a placebo group
Conditions studied: Gastroenteric Tract, Respiratory Tract, Infections, Gastroenteric Infections
In brief
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 facts
- Study ID
- NCT07050693
- Run by
- University of Bari
- People needed
- 100
- Starts
- 2025-04-17
- Expected to finish
- 2026-04-30
- Last updated by the study team
- 2025-07-09
Who can join
Age: 1 and older, up to 4. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Healthy school-going children aged 12 to 48 months who attend school at least 5 days a week
You may not qualify if…
- 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 is running
- Pediatria Trambusti — Bari, Bari, Italy (enrolling)
Full record on ClinicalTrials.gov
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