Children, Only, Diet Modification, Infectious Disease
Conditions
Brief summary
The study aims to confirm the effectiveness of chicory-derived prebiotic inulin-type fructans on the reduction of the number of febrile infections diagnosed by the paediatrician in children.
Interventions
DIETARY_SUPPLEMENTprebiotic inulin-type fructans
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
* Suffering from current infection or has suffered from infection in previous 7 days * Intake of antibiotics and/or laxatives in the previous 14 days prior to start of the intervention * children with known gastrointestinal disease or malformation * children with congenital or acquired immunodeficiency * children with food intolerance, food allergy * children that regularly consume (more than 3 times per week) probiotic products or a food supplement containing prebiotics * children involved in any clinical or food study within the preceding 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of febrile infectious episodes diagnosed by paediatrician | 6 months period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of paediatrician´s consultations due to infectious disease and/ or symptoms of dysbiosis (diarrhoea) following antibiotic treatment | 6 months period | — |
| Number of episodes of medication use (including prescribed/ non-prescribed medication and antibiotics/ non-antibiotics) | 6 months period | — |
| Number of days of medication use (including prescribed/ non-prescribed medication and antibiotics/ non-antibiotics) | 6 months period | — |
| Quality of life reported by the parents according to standardized questionnaire | 6 months period | Parent Diary (scale: no, minor, moderate, significant changes, Not known) |
| Analysis of stool samples in a subset of children: microbiota changes | 6 months period | — |
| Number of any infectious episodes diagnosed by paediatrician | 6 months period | — |
| Number of episodes with symptoms of illnesses indicating a viral or bacterial infection | 6 months period | — |
| Duration of febrile infectious episodes diagnosed by the paediatrician | 6 months period | — |
| Duration of any infectious episode | 6 months period | — |
| Duration of episodes with symptoms of illnesses indicating a viral or bacterial infection | 6 months period | — |
| Days of absence from day-care of the child due to infectious episodes and/or symptoms of dysbiosis (diarrhoea) following antibiotic treatment | 6 months period | — |
| Hospitalization days due to infectious disease and/or symptoms of dysbiosis | 6 months period | — |
| Number of days (parents questionnaire and diary) of caretaker´s absenteeism from work due to infectious episodes and/or symptoms of dysbiosis of the child | 6 months period | — |
| Number of episodes on antibiotic treatment | 6 months period | — |
| Number of days on antibiotic treatment | 6 months period | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Body Height | 6 months period | Main Parameters of safety |
| Side effects (Questionnaire) | 6 months period | Main Parameters of safety |
| Incidence of gastrointestinal discomfort | 6 months period | Main Parameters of safety |
| Body Weight | 6 months period | Main Parameters of safety |
Outcome results
None listed