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

Not Applicable

Completed

• Conditions: Children, Only; Infectious Disease; Diet Modification

• Registration Number: NCT03457688
• Lead Sponsor: Beneo-Institute

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09-19
• Primary Completion: 2017-05-01
• Study Completion: 2017-05-01
• Study First Submitted: 2018-02-21
• Status Verified: 2018-03
• Study First Submitted QC: 2018-03-01
• Study First Posted: 2018-03-07
• Last Update Submitted: 2018-03-08
• Last Update Posted: 2018-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 850

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of febrile infectious episodes diagnosed by paediatrician	6 months period

Secondary Outcome Measures

Name	Time	Method
Number of days on antibiotic treatment	6 months period
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	Parent Diary (scale: no, minor, moderate, significant changes, Not known)
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
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