Effect of Prebiotic Fructans to Reduce Number of Febrile Infections in Children

NCT03457688 | Completed

• 1 other identifier: 16002n_
• Study Type: interventional
• Target: 850
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study aims to confirm the effectiveness of chicory-derived prebiotic inulin-type fructans on the reduction of the number of febrile infections diagnosed by the paediatrician in children.

Conditions

Infectious Disease; Children, Only; Diet Modification

Outcome Measures

Primary Outcomes (1)

• Number of febrile infectious episodes diagnosed by paediatrician

  6 months period

Secondary Outcomes (15)

• Number of any infectious episodes diagnosed by paediatrician

  6 months period

• Number of episodes with symptoms of illnesses indicating a viral or bacterial infection

  6 months period

• Duration of febrile infectious episodes diagnosed by the paediatrician

  6 months period

• Duration of any infectious episode

  6 months period

• Duration of episodes with symptoms of illnesses indicating a viral or bacterial infection

  6 months period

Other Outcomes (4)

• Incidence of gastrointestinal discomfort

  6 months period

• Body Weight

  6 months period

• Body Height

  6 months period

Study Arms (2)

prebiotic inulin-type fructans

ACTIVE COMPARATOR

Dietary Supplement: prebiotic inulin-type fructans

placebo maltodextrin

PLACEBO COMPARATOR

Dietary Supplement: placebo maltodextrin

Interventions

prebiotic inulin-type fructans DIETARY_SUPPLEMENT

prebiotic inulin-type fructans

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:

• Suffering from current infection or has suffered from infection in previous 7 days
• Intake of antibiotics and/or laxatives in the previous 14 days prior to start of the intervention
• children with known gastrointestinal disease or malformation
• children with congenital or acquired immunodeficiency
• children with food intolerance, food allergy
• children that regularly consume (more than 3 times per week) probiotic products or a food supplement containing prebiotics
• children involved in any clinical or food study within the preceding 6 months

Sponsors & Collaborators

• Beneo-Institute: lead

Related Publications (1)

• 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

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: February 21, 2018
• First Posted: March 7, 2018
• Study Start: September 19, 2016
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: March 12, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share