Gastroenteric Infections, Gastroenteric Tract, Infections, Respiratory Tract
Conditions
Keywords
food supplement, gastroenteric infection
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.
Interventions
DIETARY_SUPPLEMENTVitamin + Zinc + micronutrient mixture
a dietary supplement containing Vitamin D, Zinc, Beta glucan WELLMUNE WGP, 2'Fucosyllactose.
DIETARY_SUPPLEMENTPlacebo
Placebo is identical to intervention product
Sponsors
University of Bari
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Nobody knows the randomization code
Intervention model description
Randomized double bind with placebo
Eligibility
Sex/Gender
ALL
Age
12 Months to 48 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary outcome | The dietary supplement and placebo will be administered for three months from the date of enrollment. | The primary aim of the study will be the percentage of children who will present at least one infectious episode (acute gastroenteritis, rhinitis, otitis, pharyngitis, laryngitis, tracheitis) diagnosed by the pediatrician during the 3-month study period. |
Countries
Italy
Outcome results
None listed