Clinical trial NCT03457688: Effect of Prebiotic Fructans to Reduce Number of Febrile Infections in Children
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infectious Disease
Children, Only
Diet Modification
Lead sponsor: Beneo-Institute
Sponsor class: INDUSTRY
First posted: 2018-03-07
Enrollment: 850
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of febrile infectious episodes diagnosed by paediatrician
timeFrame: 6 months period
Secondary outcomes:
measure: Number of any infectious episodes diagnosed by paediatrician
timeFrame: 6 months period
measure: Number of episodes with symptoms of illnesses indicating a viral or bacterial infection
timeFrame: 6 months period
measure: Duration of febrile infectious episodes diagnosed by the paediatrician
timeFrame: 6 months period
measure: Duration of any infectious episode
timeFrame: 6 months period
measure: Duration of episodes with symptoms of illnesses indicating a viral or bacterial infection
timeFrame: 6 months period
measure: Days of absence from day-care of the child due to infectious episodes and/or symptoms of dysbiosis (diarrhoea) following antibiotic treatment
timeFrame: 6 months period
measure: Number of paediatrician´s consultations due to infectious disease and/ or symptoms of dysbiosis (diarrhoea) following antibiotic treatment
timeFrame: 6 months period
measure: Hospitalization days due to infectious disease and/or symptoms of dysbiosis
timeFrame: 6 months period
measure: 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
timeFrame: 6 months period
measure: Number of episodes on antibiotic treatment
timeFrame: 6 months period
measure: Number of days on antibiotic treatment
timeFrame: 6 months period
measure: Number of episodes of medication use (including prescribed/ non-prescribed medication and antibiotics/ non-antibiotics)
timeFrame: 6 months period
measure: Number of days of medication use (including prescribed/ non-prescribed medication and antibiotics/ non-antibiotics)
timeFrame: 6 months period
measure: Quality of life reported by the parents according to standardized questionnaire
timeFrame: 6 months period
measure: Analysis of stool samples in a subset of children: microbiota changes
timeFrame: 6 months period
Other outcomes:
measure: Incidence of gastrointestinal discomfort
timeFrame: 6 months period
measure: Body Weight
timeFrame: 6 months period
measure: Body Height
timeFrame: 6 months period
measure: Side effects (Questionnaire)
timeFrame: 6 months period
Locations:
Study officials:
affiliation: Department of Paediatrics, University of Pécs, Hungary
name: Tamás Decsi, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.