<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/NCT02244047</url>
  </required_header>
  <id_info>
    <org_study_id>CEL-BIF</org_study_id>
    <nct_id>NCT02244047</nct_id>
  </id_info>
  <brief_title>Cytokine Profile in Children With Celiac Disease</brief_title>
  <official_title>Exploratory, Placebo-controlled Study on the Effects of Bifidobacterium Breve in Children With Celiac Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Medical Centre Maribor</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Slovenian Research Agency</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Medical Centre Maribor</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Celiac disease (CD) is an immune-mediated systemic disease that is elicited by consumption of&#xD;
      gluten and related prolamines in genetically susceptible individuals. Not only genetic but&#xD;
      also environmental factors play an important role in CD pathogenesis. CD patients have&#xD;
      imbalance in the gut microbiota, they have reduced number of Bididobacterium species in feces&#xD;
      and biopsies.&#xD;
&#xD;
      Up till now, only effective treatment for CD is life long adherence to gluten free diet. If&#xD;
      gluten free diet is not strict that leads over the years to complications of disease, such as&#xD;
      autoimmune diseases, psychiatric diseases, osteoporosis etc. That may be caused by continuous&#xD;
      recirculation of activated immune cells between the inflamed organ and the periphery. To&#xD;
      avoid complications of disease in long term the investigators want to test specific probiotic&#xD;
      bacteria from Bifidobacteria genus, that has has been in vitro studies recognized as&#xD;
      anti-inflammatory.&#xD;
&#xD;
      Hypothesis&#xD;
&#xD;
        1. Children with celiac disease on gluten free diet have a higher level of pro-inflammatory&#xD;
           cytokine (TNF-alpha) and anti-inflammatory cytokine (IL-10) in comparison with healthy&#xD;
           controls.&#xD;
&#xD;
        2. 3 months after daily probiotic consumption TNF-alpha level decrease and IL-10 level&#xD;
           increase.&#xD;
&#xD;
      In the investigators research will be selected 70 children, age from 2 to 18 years, divided&#xD;
      in different groups:&#xD;
&#xD;
        1. Group: 25 children with celiac disease on GFD for at least 3 months and will receive&#xD;
           probiotic for 3 months.&#xD;
&#xD;
        2. Group: 25 children with celiac disease on GFD for at least 3 months and will receive&#xD;
           placebo for 3 months.&#xD;
&#xD;
        3. Group: 20 healthy children&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2013</start_date>
  <completion_date type="Actual">June 2014</completion_date>
  <primary_completion_date type="Actual">June 2014</primary_completion_date>
  <phase>Phase 1/Phase 2</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Serum TNF-alpha decrease after Bifidobacterium breve daily consumption in children with celiac disease</measure>
    <time_frame>3 months</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">66</enrollment>
  <condition>Celiac Disease</condition>
  <arm_group>
    <arm_group_label>Bifidobacterium breve</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Bifidobacterium breve BR03 and B632 powder containing 10/9 CFU daily dosage in a period of 3 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Placebo in the same powder packages as Bifidobacterium breve</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bifidobacterium breve</intervention_name>
    <arm_group_label>Bifidobacterium breve</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo (for Bifidobacterium breve)</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  celiac disease on gluten free diet&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  acute or chronic diseases,&#xD;
&#xD;
          -  permanent use of medication and&#xD;
&#xD;
          -  ingestion of antibiotics at least one month prior to study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Martina Klemenak, md</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Medical Centre Maribor</affiliation>
  </overall_official>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 16, 2014</study_first_submitted>
  <study_first_submitted_qc>September 17, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 18, 2014</study_first_posted>
  <last_update_submitted>September 17, 2014</last_update_submitted>
  <last_update_submitted_qc>September 17, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 18, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Medical Centre Maribor</investigator_affiliation>
    <investigator_full_name>Martina Klemenak</investigator_full_name>
    <investigator_title>medical doctor, resident at Pediatric department</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Celiac Disease</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>October 25, 2016</submitted>
    <returned>December 16, 2016</returned>
  </pending_results>
  <!-- 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/NCT02244047
org study id: CEL-BIF
nct id: NCT02244047
lead sponsor: 
collaborator: 
has dmc: No
Celiac disease (CD) is an immune-mediated systemic disease that is elicited by consumption of
      gluten and related prolamines in genetically susceptible individuals. Not only genetic but
      also environmental factors play an important role in CD pathogenesis. CD patients have
      imbalance in the gut microbiota, they have reduced number of Bididobacterium species in feces
      and biopsies.

      Up till now, only effective treatment for CD is life long adherence to gluten free diet. If
      gluten free diet is not strict that leads over the years to complications of disease, such as
      autoimmune diseases, psychiatric diseases, osteoporosis etc. That may be caused by continuous
      recirculation of activated immune cells between the inflamed organ and the periphery. To
      avoid complications of disease in long term the investigators want to test specific probiotic
      bacteria from Bifidobacteria genus, that has has been in vitro studies recognized as
      anti-inflammatory.

      Hypothesis

        1. Children with celiac disease on gluten free diet have a higher level of pro-inflammatory
           cytokine (TNF-alpha) and anti-inflammatory cytokine (IL-10) in comparison with healthy
           controls.

        2. 3 months after daily probiotic consumption TNF-alpha level decrease and IL-10 level
           increase.

      In the investigators research will be selected 70 children, age from 2 to 18 years, divided
      in different groups:

        1. Group: 25 children with celiac disease on GFD for at least 3 months and will receive
           probiotic for 3 months.

        2. Group: 25 children with celiac disease on GFD for at least 3 months and will receive
           placebo for 3 months.

        3. Group: 20 healthy children
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: Serum TNF-alpha decrease after Bifidobacterium breve daily consumption in children with celiac disease
time frame: 3 months
arm group label: Bifidobacterium breve
arm group type: Active Comparator
description: Bifidobacterium breve BR03 and B632 powder containing 10/9 CFU daily dosage in a period of 3 months
arm group label: Placebo
arm group type: Active Comparator
description: Placebo in the same powder packages as Bifidobacterium breve
intervention type: Drug
intervention name: Bifidobacterium breve
arm group label: Bifidobacterium breve
intervention type: Drug
intervention name: Placebo (for Bifidobacterium breve)
arm group label: Placebo
criteria: 
gender: All
minimum age: 1 Year
maximum age: 18 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Martina Klemenak, md
role: Principal Investigator
affiliation: University Medical Centre Maribor
responsible party type: Principal Investigator
investigator affiliation: University Medical Centre Maribor
investigator full name: Martina Klemenak
investigator title: medical doctor, resident at Pediatric department
mesh term: Celiac Disease
submitted: October 25, 2016
returned: December 16, 2016