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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| prebiotic inulin-type fructans | Active Comparator |
| |
| placebo maltodextrin | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| prebiotic inulin-type fructans | Dietary Supplement |
| ||
| placebo maltodextrin |
| Measure | Description | Time Frame |
|---|---|---|
| Number of febrile infectious episodes diagnosed by paediatrician | 6 months period |
| 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 | |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of gastrointestinal discomfort | Main Parameters of safety | 6 months period |
| Body Weight | Main Parameters of safety | 6 months period |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tamás Decsi, Prof. | Department of Paediatrics, University of Pécs, Hungary | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24903007 | Background | Lohner S, Kullenberg D, Antes G, Decsi T, Meerpohl JJ. Prebiotics in healthy infants and children for prevention of acute infectious diseases: a systematic review and meta-analysis. Nutr Rev. 2014 Aug;72(8):523-31. doi: 10.1111/nure.12117. Epub 2014 Jun 5. |
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| ID | Term |
|---|---|
| D003141 | Communicable Diseases |
| ID | Term |
|---|---|
| D007239 | Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Dietary Supplement |
|
| 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 |
| Body Height | Main Parameters of safety | 6 months period |
| Side effects (Questionnaire) | Main Parameters of safety | 6 months period |