Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07050693

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Gastroenteric Tract Gastroenteric Infections Infections Respiratory Tract

Age range

12 month–48 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin + Zinc + micronutrient mixture

Dietary Supplement

a dietary supplement containing Vitamin D, Zinc, Beta glucan WELLMUNE WGP, 2'Fucosyllactose.

Other names: Experimental arm

Placebo

Dietary Supplement

Placebo is identical to intervention product

Primary outcomes

  1. Primary outcome

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Bari

Other

Registry information

Official study title

Efficacy of A 2'-Fucosylactose-based Food Supplement on the Prevention of Respiratory and Gastrointestinal Infections in Schhol-attended Children: a Randomized, Double-blind, Placebo-controlled Trial.

Acronym: IMMUNOSICK24

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jul 3, 2025
Registry last updated
Jul 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.