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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03241355
Other study ID # 13004n_Fructan_Study
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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