Prebiotic Fructans on the Incidence of Acute Infectious Diseases in Children

Diet Modification Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03241355
• Other study ID #: 13004n_Fructan_Study
• Status: Completed
• Phase: N/A
• Start date: September 16, 2013
• Est. completion date: April 28, 2014

Study information

• Verified date: August 2018
• Source: Beneo-Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 258
• Est. completion date: April 28, 2014
• Est. primary completion date: April 28, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Children, Only
• Communicable Diseases
• Diet Modification
• Infection
• Infectious Disease

Intervention

Dietary Supplement:
• prebiotic inulin-type fructan

• Placebo maltodextrin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Beneo-Institute

References & Publications (2)

Lohner S, Jakobik V, Mihályi K, Soldi S, Vasileiadis S, Theis S, Sailer M, Sieland C, Berényi 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 Fe — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of infectious disease episodes		24 weeks period
Secondary	microbiota composition	fecal microbiota composition (qPCR, illumina)	24 weeks period