Double-blind, Parallel, Randomized, (Placebo-controlled) Explorative Study on the Effect of a Mixture of Prebiotic Oligosaccharides on the Composition of Intestinal Microbiota and Selected Health Outcomes in Children 3 to 6 Years of Age

Beneo-Institute0 sites258 target enrollmentSeptember 16, 2013

ConditionsChildren, Only Diet Modification Infectious Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Children, Only
Sponsor: Beneo-Institute
Enrollment: 258
Primary Endpoint: Frequency of infectious disease episodes
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 16, 2013

End Date

April 28, 2014

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Beneo-Institute

Responsible Party

Sponsor

Eligibility Criteria

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