Prebiotic Fructans on the Incidence of Acute Infectious Diseases in Children

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.

Completed

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Key information

Conditions

Infectious Disease Children, Only Communicable Diseases Diet Modification Disease Attributes Infections Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

3 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

prebiotic inulin-type fructan

Dietary Supplement

Placebo Maltodextrin

Dietary Supplement

Primary outcomes

Frequency of infectious disease episodes

Time frame: 24 weeks period

Secondary outcomes

microbiota composition

Time frame: 24 weeks period

fecal microbiota composition (qPCR, illumina)

Sponsors and collaborators

Lead sponsor

Beneo-Institute

Industry

Registry information

Official study title

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

Important dates

Study start: 2013
Primary completion: 2014
Study completion: 2014
First posted: Aug 7, 2017
Registry last updated: Aug 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed