Prebiotic Fructans on the Incidence of Acute Infectious Diseases in Children

Sponsor

Beneo-Institute (Industry)

Overall Status

Completed

CT.gov ID

NCT03241355

Collaborator

(none)

258

Enrollment

Arms

7.4

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Infectious Disease Children, Only Diet Modification	Dietary Supplement: prebiotic inulin-type fructan Dietary Supplement: Placebo maltodextrin	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

258 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official 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

Actual Study Start Date :

Sep 16, 2013

Actual Primary Completion Date :

Apr 28, 2014

Actual Study Completion Date :

Apr 28, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: prebiotic inulin-type fructan	Dietary Supplement: prebiotic inulin-type fructan
Placebo Comparator: placebo maltodextrin	Dietary Supplement: Placebo maltodextrin

Arm

Intervention/Treatment

Active Comparator: prebiotic inulin-type fructan

Dietary Supplement: prebiotic inulin-type fructan

Placebo Comparator: placebo maltodextrin

Dietary Supplement: Placebo maltodextrin

Outcome Measures

Primary Outcome Measures

Frequency of infectious disease episodes [24 weeks period]

Secondary Outcome Measures

microbiota composition [24 weeks period]
fecal microbiota composition (qPCR, illumina)

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years to 6 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Beneo-Institute

Investigators

Principal Investigator: Tamás Decsi, Prof., Department of Paediatrics, University of Pécs, Hungary

Study Documents (Full-Text)

None provided.

More Information

Publications

Lohner S, Küllenberg D, Antes G, Decsi T, Meerpohl JJ. Prebiotics in healthy infants and children for prevention of acute infectious diseases: a systematic review and meta-analysis. Nutr Rev. 2014 Aug;72(8):523-31. doi: 10.1111/nure.12117. Epub 2014 Jun 5. Review.

Responsible Party:

Beneo-Institute

ClinicalTrials.gov Identifier:

NCT03241355

Other Study ID Numbers:

13004n_Fructan_Study

First Posted:

Aug 7, 2017

Last Update Posted:

Aug 28, 2018

Last Verified:

Aug 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Communicable Diseases

Infections

Study Results

No Results Posted as of Aug 28, 2018