Efficacy of a 2'-Fucosylactose-based Food Supplement on the Prevention of Respiratory and Gastrointestinal Infections.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Vitamin + Zinc + micronutrient mixture, Placebo.
- Who it may be relevant to
- Registry conditions: Gastroenteric Tract, Respiratory Tract, Infections, Gastroenteric Infections. Basic parameters: 12 months — 48 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official 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.
Overview
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 supplement Vitamin + Zinc + micronutrient mixture
a dietary supplement containing Vitamin D, Zinc, Beta glucan WELLMUNE WGP, 2'Fucosyllactose. - Dietary supplement Placebo
Placebo is identical to intervention product
Primary outcome measures
- Primary outcome [Time frame: The dietary supplement and placebo will be administered for three months from the date of enrollment.]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Prevention
Study locations
Italy · 1 center
- Pediatria Trambusti — Bari
Publications
- 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
- 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
- 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
Identifiers
NCT: NCT07050693 · IMMUNOSICK24