Prebiotic Fructans on the Incidence of Acute Infectious Diseases in Children

Not Applicable

Completed

• Conditions: Children, Only; Diet Modification; Infectious Disease
• Interventions: Dietary Supplement: Placebo maltodextrin; Dietary Supplement: prebiotic inulin-type fructan

• Registration Number: NCT03241355
• Lead Sponsor: Beneo-Institute

Brief Summary

The study aims to explore whether prophylactic dietary supplementation with prebiotic inulin-type fructans is able to influence the intestinal microbiota and the frequency of infectious disease episodes in kindergarten children during a winter period.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09-16
• Primary Completion: 2014-04-28
• Study Completion: 2014-04-28
• Study First Submitted: 2017-08-03
• Study First Submitted QC: 2017-08-03
• Study First Posted: 2017-08-07
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-27
• Last Update Posted: 2018-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 258

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

• congenital disease or malformation influencing the gastrointestinal System
• children with congenital or acquired immunodeficiency
• children with food intolerance, food allergy or metabolic disorder requiring special diet
• children who regularly (more than 3 times per week) consumed products or food supplements containing prebiotics or probiotics
• children who consumed antibiotics or laxatives within 14 days
• children who had any infectious disease within 14 days at the time of pre-examination

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo maltodextrin	Placebo maltodextrin	-
prebiotic inulin-type fructan	prebiotic inulin-type fructan	-

Primary Outcome Measures

Name	Time	Method
Frequency of infectious disease episodes	24 weeks period

Secondary Outcome Measures

Name	Time	Method
microbiota composition	24 weeks period	fecal microbiota composition (qPCR, illumina)