Prebiotic Fructans on the Incidence of Acute Infectious Diseases in Children

Not Applicable

Completed

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

• 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

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)