Actively Recruiting

Phase Not Applicable
Age: 12Months - 48Months
All Genders
NCT07050693

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

Led by University of Bari · Updated on 2025-07-09

100

Participants Needed

1

Research Sites

54 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 12Months - 48Months
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Healthy school-going children aged 12 to 48 months who attend school at least 5 days a week
Not Eligible

You will not qualify if you...

  • Age less than 12 months or more than 48 months
  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Pediatria Trambusti

Bari, Bari, Italy, 70100

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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