NCT07050693 Efficacy of a 2'-Fucosylactose-based Food Supplement on the Prevention of Respiratory and Gastrointestinal Infections.
| NCT ID | NCT07050693 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Bari |
| Condition | Gastroenteric Tract |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-04-17 |
| Primary Completion | 2025-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2025-04-17 with a primary completion date of 2025-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Frequently Asked Questions
Who can join the NCT07050693 clinical trial?
This trial is open to participants of all sexes, aged 12 Months or older, up to 48 Months, studying Gastroenteric Tract. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07050693 currently recruiting?
Yes, NCT07050693 is actively recruiting participants. Visit ClinicalTrials.gov or contact University of Bari to inquire about joining.
Where is the NCT07050693 trial being conducted?
This trial is being conducted at Bari, Italy.
Who is sponsoring the NCT07050693 clinical trial?
NCT07050693 is sponsored by University of Bari. The trial plans to enroll 100 participants.