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

NCT07050693 | Recruiting

• 1 other identifier: IMMUNOSICK24
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastroenteric Tract; Respiratory Tract; Infections; Gastroenteric Infections

Keywords

food supplement; gastroenteric infection

Outcome Measures

Primary Outcomes (1)

• Primary outcome

  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.

  The dietary supplement and placebo will be administered for three months from the date of enrollment.

Study Arms (2)

Experimental

EXPERIMENTAL

50 children will take the product under study based on Vitamin D, Zinc, Beta glucan, 2'Fucosyllactose

Dietary Supplement: Vitamin + Zinc + micronutrient mixture

Placebo

PLACEBO COMPARATOR

50 children will take a carbohydrate-based control product (maltodextrin)

Dietary Supplement: Placebo

Interventions

Vitamin + Zinc + micronutrient mixture DIETARY_SUPPLEMENT

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

Also known as: Experimental arm

Experimental

Placebo DIETARY_SUPPLEMENT

Placebo is identical to intervention product

Placebo

Eligibility Criteria

• Age: 12 Months - 48 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Healthy school-going children aged 12 to 48 months who attend school at least 5 days a week

You may not qualify if:

• 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;

Sponsors & Collaborators

• University of Bari: lead

Study Sites (1)

Pediatria Trambusti

Bari, Bari, 70100, Italy

RECRUITING

Related Publications (3)

• Siziba LP, Mank M, Stahl B, Kurz D, Gonsalves J, Blijenberg B, Rothenbacher D, Genuneit J. Associations of Human Milk Oligosaccharides With Otitis Media and Lower and Upper Respiratory Tract Infections up to 2 Years: The Ulm SPATZ Health Study. Front Nutr. 2021 Oct 25;8:761129. doi: 10.3389/fnut.2021.761129. eCollection 2021.

  PMID: 34760912 BACKGROUND

• Etzold S, Bode L. Glycan-dependent viral infection in infants and the role of human milk oligosaccharides. Curr Opin Virol. 2014 Aug;7:101-7. doi: 10.1016/j.coviro.2014.06.005. Epub 2014 Jul 19.

  PMID: 25047751 BACKGROUND

• Hatakka K, Savilahti E, Ponka A, Meurman JH, Poussa T, Nase L, Saxelin M, Korpela R. Effect of long term consumption of probiotic milk on infections in children attending day care centres: double blind, randomised trial. BMJ. 2001 Jun 2;322(7298):1327. doi: 10.1136/bmj.322.7298.1327.

  PMID: 11387176 BACKGROUND

MeSH Terms

Conditions

Infections

Interventions

Vitamins; Zinc

Intervention Hierarchy (Ancestors)

Micronutrients; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Nutrients; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Nobody knows the randomization code
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomized double bind with placebo

Study Record Dates

• First Submitted: March 21, 2025
• First Posted: July 3, 2025
• Study Start: April 17, 2025
• Primary Completion: September 1, 2025
• Study Completion: April 30, 2026
• Last Updated: July 9, 2025

Record last verified: 2025-06

Locations

IT (1)