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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-17

Study Completion Date

2026-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Gastroenteric Tract Respiratory Tract Infections Gastroenteric Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized double bind with placebo

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Nobody knows the randomization code

Study Groups

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Experimental

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

Group Type EXPERIMENTAL

Vitamin + Zinc + micronutrient mixture

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo is identical to intervention product

Interventions

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Vitamin + Zinc + micronutrient mixture

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo is identical to intervention product

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Experimental arm

Eligibility Criteria

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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

Minimum Eligible Age

12 Months

Maximum Eligible Age

48 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No