Back to resultsPrebiotic Fructans on the Incidence of Acute Infectious Diseases in Children
Primary Purpose
Infectious Disease, Children, Only, Diet Modification
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
prebiotic inulin-type fructan
Placebo maltodextrin
Sponsored by
About this trial
This is an interventional prevention trial for Infectious Disease
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
prebiotic inulin-type fructan
placebo maltodextrin
Arm Description
Outcomes
Primary Outcome Measures
Frequency of infectious disease episodes
Secondary Outcome Measures
microbiota composition
fecal microbiota composition (qPCR, illumina)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03241355
Brief Title
Prebiotic Fructans on the Incidence of Acute Infectious Diseases in Children
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
September 16, 2013 (Actual)
Primary Completion Date
April 28, 2014 (Actual)
Study Completion Date
April 28, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beneo-Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infectious Disease, Children, Only, Diet Modification
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
258 (Actual)
8. Arms, Groups, and Interventions
Arm Title
prebiotic inulin-type fructan
Arm Type
Active Comparator
Arm Title
placebo maltodextrin
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
prebiotic inulin-type fructan
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo maltodextrin
Primary Outcome Measure Information:
Title
Frequency of infectious disease episodes
Time Frame
24 weeks period
Secondary Outcome Measure Information:
Title
microbiota composition
Description
fecal microbiota composition (qPCR, illumina)
Time Frame
24 weeks period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tamás Decsi, Prof.
Organizational Affiliation
Department of Paediatrics, University of Pécs, Hungary
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
24903007
Citation
Lohner S, Kullenberg 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.
Results Reference
background
PubMed Identifier
29982534
Citation
Lohner S, Jakobik V, Mihalyi K, Soldi S, Vasileiadis S, Theis S, Sailer M, Sieland C, Berenyi K, Boehm G, Decsi T. Inulin-Type Fructan Supplementation of 3- to 6-Year-Old Children Is Associated with Higher Fecal Bifidobacterium Concentrations and Fewer Febrile Episodes Requiring Medical Attention. J Nutr. 2018 Aug 1;148(8):1300-1308. doi: 10.1093/jn/nxy120.
Results Reference
result
PubMed Identifier
30776899
Citation
Soldi S, Vasileiadis S, Lohner S, Uggeri F, Puglisi E, Molinari P, Donner E, Sieland C, Decsi T, Sailer M, Theis S. Prebiotic supplementation over a cold season and during antibiotic treatment specifically modulates the gut microbiota composition of 3-6 year-old children. Benef Microbes. 2019 Apr 19;10(3):253-263. doi: 10.3920/BM2018.0116. Epub 2019 Feb 19.
Results Reference
derived
Learn more about this trial
Prebiotic Fructans on the Incidence of Acute Infectious Diseases in Children
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