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

Primary Purpose

Infectious Disease, Children, Only, Diet Modification

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
prebiotic inulin-type fructans
placebo maltodextrin
Sponsored by
Beneo-Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Infectious Disease

Eligibility Criteria

3 Years - 6 Years (Child)All SexesAccepts Healthy Volunteers

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:

  • 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    prebiotic inulin-type fructans

    placebo maltodextrin

    Arm Description

    Outcomes

    Primary Outcome Measures

    Number of febrile infectious episodes diagnosed by paediatrician

    Secondary Outcome Measures

    Number of any infectious episodes diagnosed by paediatrician
    Number of episodes with symptoms of illnesses indicating a viral or bacterial infection
    Duration of febrile infectious episodes diagnosed by the paediatrician
    Duration of any infectious episode
    Duration of episodes with symptoms of illnesses indicating a viral or bacterial infection
    Days of absence from day-care of the child due to infectious episodes and/or symptoms of dysbiosis (diarrhoea) following antibiotic treatment
    Number of paediatrician´s consultations due to infectious disease and/ or symptoms of dysbiosis (diarrhoea) following antibiotic treatment
    Hospitalization days due to infectious disease and/or symptoms of dysbiosis
    Number of days (parents questionnaire and diary) of caretaker´s absenteeism from work due to infectious episodes and/or symptoms of dysbiosis of the child
    Number of episodes on antibiotic treatment
    Number of days on antibiotic treatment
    Number of episodes of medication use (including prescribed/ non-prescribed medication and antibiotics/ non-antibiotics)
    Number of days of medication use (including prescribed/ non-prescribed medication and antibiotics/ non-antibiotics)
    Quality of life reported by the parents according to standardized questionnaire
    Parent Diary (scale: no, minor, moderate, significant changes, Not known)
    Analysis of stool samples in a subset of children: microbiota changes

    Full Information

    First Posted
    February 21, 2018
    Last Updated
    March 8, 2018
    Sponsor
    Beneo-Institute
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03457688
    Brief Title
    Effect of Prebiotic Fructans to Reduce Number of Febrile Infections in Children
    Official Title
    Double-blind, Randomized Placebo-controlled, Multi-center Trial Investigating the Effect of Prebiotic Inulin-type Fructans on Infectious Incidence in Children Aged 3 to 6 Years
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    September 19, 2016 (Actual)
    Primary Completion Date
    May 1, 2017 (Actual)
    Study Completion Date
    May 1, 2017 (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 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.

    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
    850 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    prebiotic inulin-type fructans
    Arm Type
    Active Comparator
    Arm Title
    placebo maltodextrin
    Arm Type
    Placebo Comparator
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    prebiotic inulin-type fructans
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    placebo maltodextrin
    Primary Outcome Measure Information:
    Title
    Number of febrile infectious episodes diagnosed by paediatrician
    Time Frame
    6 months period
    Secondary Outcome Measure Information:
    Title
    Number of any infectious episodes diagnosed by paediatrician
    Time Frame
    6 months period
    Title
    Number of episodes with symptoms of illnesses indicating a viral or bacterial infection
    Time Frame
    6 months period
    Title
    Duration of febrile infectious episodes diagnosed by the paediatrician
    Time Frame
    6 months period
    Title
    Duration of any infectious episode
    Time Frame
    6 months period
    Title
    Duration of episodes with symptoms of illnesses indicating a viral or bacterial infection
    Time Frame
    6 months period
    Title
    Days of absence from day-care of the child due to infectious episodes and/or symptoms of dysbiosis (diarrhoea) following antibiotic treatment
    Time Frame
    6 months period
    Title
    Number of paediatrician´s consultations due to infectious disease and/ or symptoms of dysbiosis (diarrhoea) following antibiotic treatment
    Time Frame
    6 months period
    Title
    Hospitalization days due to infectious disease and/or symptoms of dysbiosis
    Time Frame
    6 months period
    Title
    Number of days (parents questionnaire and diary) of caretaker´s absenteeism from work due to infectious episodes and/or symptoms of dysbiosis of the child
    Time Frame
    6 months period
    Title
    Number of episodes on antibiotic treatment
    Time Frame
    6 months period
    Title
    Number of days on antibiotic treatment
    Time Frame
    6 months period
    Title
    Number of episodes of medication use (including prescribed/ non-prescribed medication and antibiotics/ non-antibiotics)
    Time Frame
    6 months period
    Title
    Number of days of medication use (including prescribed/ non-prescribed medication and antibiotics/ non-antibiotics)
    Time Frame
    6 months period
    Title
    Quality of life reported by the parents according to standardized questionnaire
    Description
    Parent Diary (scale: no, minor, moderate, significant changes, Not known)
    Time Frame
    6 months period
    Title
    Analysis of stool samples in a subset of children: microbiota changes
    Time Frame
    6 months period
    Other Pre-specified Outcome Measures:
    Title
    Incidence of gastrointestinal discomfort
    Description
    Main Parameters of safety
    Time Frame
    6 months period
    Title
    Body Weight
    Description
    Main Parameters of safety
    Time Frame
    6 months period
    Title
    Body Height
    Description
    Main Parameters of safety
    Time Frame
    6 months period
    Title
    Side effects (Questionnaire)
    Description
    Main Parameters of safety
    Time Frame
    6 months 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: 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
    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
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    Effect of Prebiotic Fructans to Reduce Number of Febrile Infections in Children

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