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
| Registry | NCT03457688 |
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| Status | Completed |
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| Phase | Not applicable |
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| Study type | Interventional; randomized, parallel, masking: quadruple, prevention |
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| Enrollment | 850 (Actual) |
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| Sponsor | Beneo-Institute (Industry) |
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| Conditions | Infectious Disease, Children, Only, Diet Modification |
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| Interventions | prebiotic inulin-type fructans, placebo maltodextrin (Dietary supplement) |
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| Dates | start 2016-09-19, primary completion 2017-05-01, completion 2017-05-01, first posted 2018-03-07, last updated 2018-03-12 |
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All trials for Infectious Disease All trials for Children, Only All trials of prebiotic inulin-type fructans All trials of placebo maltodextrin
-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.
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+Arms and interventions
| Arm | Type | Interventions | Description |
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| prebiotic inulin-type fructans | Active comparator | Dietary Supplement: prebiotic inulin-type fructans | |
| placebo maltodextrin | Placebo comparator | Dietary Supplement: placebo maltodextrin | |
- prebiotic inulin-type fructans (Dietary supplement)
- placebo maltodextrin (Dietary supplement)
+Outcome measures
Primary outcomes
- Number of febrile infectious episodes diagnosed by paediatrician [6 months period]
Secondary outcomes
- 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 [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]
Other outcomes
- Incidence of gastrointestinal discomfort [6 months period]: Main Parameters of safety
- Body Weight [6 months period]: Main Parameters of safety
- Body Height [6 months period]: Main Parameters of safety
- Side effects (Questionnaire) [6 months period]: Main Parameters of safety
+Eligibility
Sex: All, ages: 3 Years to 6 Years, 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:
* 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
+Publications
- 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. PMID 24903007
+Investigators
- Tamás Decsi, Prof., Principal investigator, Department of Paediatrics, University of Pécs, Hungary