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

Launched by UNIVERSITY OF BARI · Jun 30, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at whether a special food supplement containing 2’-fucosyllactose, a natural sugar found in breast milk, can help prevent common respiratory (breathing) and stomach infections in young children. These infections often happen in kids under 4 years old, especially once they start going to school, because their immune systems and body defenses are still developing. The supplement is thought to help by supporting the immune system and stopping harmful germs from sticking to the body’s surfaces.

The study is recruiting healthy children between 1 and 4 years old who go to school at least five days a week. Children with certain health problems or conditions, such as chronic illnesses, food allergies, or recent antibiotic use, cannot join. If a child takes part, parents can expect careful monitoring over time to see if the supplement helps reduce how often and how seriously their child gets respiratory or stomach infections. This trial aims to find an easy, natural way to keep little kids healthier as they grow and learn.

Gender

ALL

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