Children, Only, Diet Modification, Infectious Disease
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTprebiotic inulin-type fructan
DIETARY_SUPPLEMENTPlacebo maltodextrin
Sponsors
Beneo-Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Years to 6 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of infectious disease episodes | 24 weeks period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| microbiota composition | 24 weeks period | fecal microbiota composition (qPCR, illumina) |
Outcome results
None listed