Prebiotic Fructans on the Incidence of Acute Infectious Diseases in Children

August 27, 2018 updated by: Beneo-Institute

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

258

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 6 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: prebiotic inulin-type fructan
Dietary supplement: prebiotic inulin-type fructan
PLACEBO_COMPARATOR: placebo maltodextrin
Dietary supplement: Placebo maltodextrin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Frequency of infectious disease episodes
Time Frame: 24 weeks period
24 weeks period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
microbiota composition
Time Frame: 24 weeks period
fecal microbiota composition (qPCR, illumina)
24 weeks period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beneo-Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 16, 2013

Primary Completion (ACTUAL)

April 28, 2014

Study Completion (ACTUAL)

April 28, 2014

Study Registration Dates

First Submitted

August 3, 2017

First Submitted That Met QC Criteria

August 3, 2017

First Posted (ACTUAL)

August 7, 2017

Study Record Updates

Last Update Posted (ACTUAL)

August 28, 2018

Last Update Submitted That Met QC Criteria

August 27, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13004n_Fructan_Study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Infectious Disease

Clinical Trials on prebiotic inulin-type fructan

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Congo, DR of

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe