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

Beneo-Institute850 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

850

Conditions

Infectious Disease Children, Only Diet Modification

Interventions

prebiotic inulin-type fructansDIETARY_SUPPLEMENT

placebo maltodextrinDIETARY_SUPPLEMENT

Eligibility

Sex: ALLMin age: 3 YearsMax age: 6 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Number of any infectious episodes diagnosed by paediatrician

Time frame: 6 months period

Number of episodes with symptoms of illnesses indicating a viral or bacterial infection

Time frame: 6 months period

Duration of febrile infectious episodes diagnosed by the paediatrician

Time frame: 6 months period

Duration of any infectious episode

Time frame: 6 months period

Duration of episodes with symptoms of illnesses indicating a viral or bacterial infection

Time frame: 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

Time frame: 6 months period

Number of paediatrician´s consultations due to infectious disease and/ or symptoms of dysbiosis (diarrhoea) following antibiotic treatment

Time frame: 6 months period

Hospitalization days due to infectious disease and/or symptoms of dysbiosis

Time frame: 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

Data from ClinicalTrials.gov

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