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

Beneo-Institute0 sites850 target enrollmentSeptember 19, 2016

ConditionsInfectious Disease Children, Only Diet Modification

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Infectious Disease
Sponsor: Beneo-Institute
Enrollment: 850
Primary Endpoint: Number of febrile infectious episodes diagnosed by paediatrician
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 19, 2016

End Date

May 1, 2017

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Beneo-Institute

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

Number of febrile infectious episodes diagnosed by paediatrician

Time Frame: 6 months period

Secondary Outcomes

Duration of febrile infectious episodes diagnosed by the paediatrician(6 months period)
Duration of episodes with symptoms of illnesses indicating a viral or bacterial infection(6 months period)
Number of days of medication use (including prescribed/ non-prescribed medication and antibiotics/ non-antibiotics)(6 months period)
Number 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)
Quality of life reported by the parents according to standardized questionnaire(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 episodes on antibiotic treatment(6 months period)
Number of days on antibiotic treatment(6 months period)
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)
Duration of any infectious episode(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 of medication use (including prescribed/ non-prescribed medication and antibiotics/ non-antibiotics)(6 months period)