Prebiotic Fructans on the Incidence of Acute Infectious Diseases in Children

NCT03241355 | Completed

• 1 other identifier: 13004n_Fructan_Study
• Study Type: interventional
• Target: 258
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Infectious Disease; Children, Only; Diet Modification

Outcome Measures

Primary Outcomes (1)

• Frequency of infectious disease episodes

  24 weeks period

Secondary Outcomes (1)

• microbiota composition

  24 weeks period

Study Arms (2)

prebiotic inulin-type fructan

ACTIVE COMPARATOR

Dietary Supplement: prebiotic inulin-type fructan

placebo maltodextrin

PLACEBO COMPARATOR

Dietary Supplement: Placebo maltodextrin

Interventions

prebiotic inulin-type fructan DIETARY_SUPPLEMENT

prebiotic inulin-type fructan

Placebo maltodextrin DIETARY_SUPPLEMENT

placebo maltodextrin

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beneo-Institute: lead

Related Publications (3)

• 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.

  PMID: 24903007 BACKGROUND

• 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.

  PMID: 29982534 RESULT

• 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.

  PMID: 30776899 DERIVED

MeSH Terms

Conditions

Communicable Diseases

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Tamás Decsi, Prof.

  Department of Paediatrics, University of Pécs, Hungary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2017
• First Posted: August 7, 2017
• Study Start: September 16, 2013
• Primary Completion: April 28, 2014
• Study Completion: April 28, 2014
• Last Updated: August 28, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share