Effect of Prebiotic Fructans to Reduce Number of Febrile Infections in Children

Study Overview
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Brief Summary
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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.

Official Title
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Double-blind, Randomized Placebo-controlled, Multi-center Trial Investigating the Effect of Prebiotic Inulin-type Fructans on Infectious Incidence in Children Aged 3 to 6 Years

Conditions
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Infectious Disease, Children, Only, Diet Modification

Intervention / Treatment
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* Dietary Supplement: prebiotic inulin-type fructans
* Dietary Supplement: placebo maltodextrin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: prebiotic inulin-type fructans<br> | Dietary Supplement: prebiotic inulin-type fructans<br> <br> |
| Placebo Comparator: placebo maltodextrin<br> | Dietary Supplement: placebo maltodextrin<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of febrile infectious episodes diagnosed by paediatrician |  | 6 months period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Number of paediatrician´s consultations due to infectious disease 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 | 
| 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 | Parent Diary (scale: no, minor, moderate, significant changes, Not known) | 6 months period | 
| Analysis of stool samples in a subset of children: microbiota changes |  | 6 months period |