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

RecruitingNAAges 12 Months - 48 MonthsAllUniversity of Bari
NCT07050693 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 immunoregulator

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📋 Eligibility rules (as published)
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
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What it tests

  • Vitamin + Zinc + micronutrient mixture
  • Placebo
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Where

1 site
Pediatria Trambusti
Bari, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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