<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03241355</url>
  </required_header>
  <id_info>
    <org_study_id>13004n_Fructan_Study</org_study_id>
    <nct_id>NCT03241355</nct_id>
  </id_info>
  <brief_title>Prebiotic Fructans on the Incidence of Acute Infectious Diseases in Children</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beneo-Institute</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Beneo-Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study aims to explore whether prophylactic dietary supplementation with prebiotic&#xD;
      inulin-type fructans is able to influence the intestinal microbiota and the frequency of&#xD;
      infectious disease episodes in kindergarten children during a winter period.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 16, 2013</start_date>
  <completion_date type="Actual">April 28, 2014</completion_date>
  <primary_completion_date type="Actual">April 28, 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Frequency of infectious disease episodes</measure>
    <time_frame>24 weeks period</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>microbiota composition</measure>
    <time_frame>24 weeks period</time_frame>
    <description>fecal microbiota composition (qPCR, illumina)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">258</enrollment>
  <condition>Infectious Disease</condition>
  <condition>Children, Only</condition>
  <condition>Diet Modification</condition>
  <arm_group>
    <arm_group_label>prebiotic inulin-type fructan</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo maltodextrin</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>prebiotic inulin-type fructan</intervention_name>
    <arm_group_label>prebiotic inulin-type fructan</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo maltodextrin</intervention_name>
    <arm_group_label>placebo maltodextrin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject is healthy at the time of pre-examination&#xD;
&#xD;
          -  Subject is aged 3-6 years at the time of pre-examination&#xD;
&#xD;
          -  Subject attends a kindergarten at the time of pre-examination&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  congenital disease or malformation influencing the gastrointestinal System&#xD;
&#xD;
          -  children with congenital or acquired immunodeficiency&#xD;
&#xD;
          -  children with food intolerance, food allergy or metabolic disorder requiring special&#xD;
             diet&#xD;
&#xD;
          -  children who regularly (more than 3 times per week) consumed products or food&#xD;
             supplements containing prebiotics or probiotics&#xD;
&#xD;
          -  children who consumed antibiotics or laxatives within 14 days&#xD;
&#xD;
          -  children who had any infectious disease within 14 days at the time of pre-examination&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>6 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tamás Decsi, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Paediatrics, University of Pécs, Hungary</affiliation>
  </overall_official>
  <reference>
    <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.</citation>
    <PMID>24903007</PMID>
  </reference>
  <results_reference>
    <citation>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.</citation>
    <PMID>29982534</PMID>
  </results_reference>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>August 3, 2017</study_first_submitted>
  <study_first_submitted_qc>August 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2017</study_first_posted>
  <last_update_submitted>August 27, 2018</last_update_submitted>
  <last_update_submitted_qc>August 27, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 28, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Infections</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03241355
org study id: 13004n_Fructan_Study
nct id: NCT03241355
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Frequency of infectious disease episodes
time frame: 24 weeks period
measure: microbiota composition
time frame: 24 weeks period
description: fecal microbiota composition (qPCR, illumina)
arm group label: prebiotic inulin-type fructan
arm group type: Active Comparator
arm group label: placebo maltodextrin
arm group type: Placebo Comparator
intervention type: Dietary Supplement
intervention name: prebiotic inulin-type fructan
arm group label: prebiotic inulin-type fructan
intervention type: Dietary Supplement
intervention name: Placebo maltodextrin
arm group label: placebo maltodextrin
criteria: 
gender: All
minimum age: 3 Years
maximum age: 6 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Tamás Decsi, Prof.
role: Principal Investigator
affiliation: Department of Paediatrics, University of Pécs, Hungary
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.
PMID: 24903007
citation: 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
responsible party type: Sponsor
mesh term: Communicable Diseases
mesh term: Infections
sharing ipd: No