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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

850 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-19

Study Completion Date

2017-05-01

Brief Summary

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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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Detailed Description

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Conditions

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Infectious Disease Children, Only Diet Modification

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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prebiotic inulin-type fructans

Group Type ACTIVE_COMPARATOR

prebiotic inulin-type fructans

Intervention Type DIETARY_SUPPLEMENT

placebo maltodextrin

Group Type PLACEBO_COMPARATOR

placebo maltodextrin

Intervention Type DIETARY_SUPPLEMENT

Interventions

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prebiotic inulin-type fructans

Intervention Type DIETARY_SUPPLEMENT

placebo maltodextrin

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

3 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes