Prebiotic Fructans on the Incidence of Acute Infectious Diseases in Children

Beneo

Status: Completed

Conditions: Children, Only; Infectious Disease; Diet Modification

Treatments: Dietary Supplement: Placebo maltodextrin; Dietary Supplement: prebiotic inulin-type fructan

Study type: Interventional

Funder types: Industry

Identifiers

NCT03241355

13004n_Fructan_Study

Details and patient eligibility

About

The study aims to explore whether prophylactic dietary supplementation with prebiotic inulin-type fructans is able to influence the intestinal microbiota and the frequency of infectious disease episodes in kindergarten children during a winter period.

Enrollment: 258 patients

Sex: All

Ages: 3 to 6 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subject is healthy at the time of pre-examination
• Subject is aged 3-6 years at the time of pre-examination
• Subject attends a kindergarten at the time of pre-examination

Exclusion criteria

• congenital disease or malformation influencing the gastrointestinal System
• children with congenital or acquired immunodeficiency
• children with food intolerance, food allergy or metabolic disorder requiring special diet
• children who regularly (more than 3 times per week) consumed products or food supplements containing prebiotics or probiotics
• children who consumed antibiotics or laxatives within 14 days
• children who had any infectious disease within 14 days at the time of pre-examination

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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258 participants in 2 patient groups, including a placebo group

prebiotic inulin-type fructan

Active Comparator group

Treatment:

Dietary Supplement: prebiotic inulin-type fructan

placebo maltodextrin

Placebo Comparator group

Treatment:

Dietary Supplement: Placebo maltodextrin