<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/NCT03815981</url>
  </required_header>
  <id_info>
    <org_study_id>1972/2017</org_study_id>
    <nct_id>NCT03815981</nct_id>
  </id_info>
  <brief_title>Siderophore-profile in Allergic and Non-allergic Subjects</brief_title>
  <official_title>Linking Iron-deficiency With Allergy- the Role of Microbial Survival Components</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Vienna</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Vienna</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>
      This study aims to profile the siderophore-content in the human gut from allergic and&#xD;
      non-allergic subjects and to assess their contribution in iron homeostasis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Iron is an essential nutrient for the majority of commensal bacteria, which commonly secrete&#xD;
      siderophores to liberate iron from their surroundings. In several studies, a misbalanced&#xD;
      microbiota has been demonstrated in allergics suggesting that also their siderophore profile&#xD;
      is severely attenuated.&#xD;
&#xD;
      There are currently no data and very limited knowledge present on the composition of&#xD;
      bacterial surviving factors in humans, or on their impact on the human immune system.&#xD;
&#xD;
      As such, 1) the iron status, 2) the microbial biota composition and the 3)&#xD;
      siderophore-profile in allergics and non-allergics will be assessed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 12, 2018</start_date>
  <completion_date type="Actual">December 12, 2021</completion_date>
  <primary_completion_date type="Actual">November 11, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Iron status</measure>
    <time_frame>baseline</time_frame>
    <description>Hemoglobin, Ferritin, hepcidin, iron and soluble transferrin receptor concentrations, transferrin saturation in %</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Siderophore profile</measure>
    <time_frame>baseline</time_frame>
    <description>Mass spectrometric analysis of siderophores</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">74</enrollment>
  <condition>Allergy</condition>
  <condition>Healthy</condition>
  <condition>Allergic Sensitisation</condition>
  <arm_group>
    <arm_group_label>Allergic</arm_group_label>
    <description>Collection of blood, stool, urin samples</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sensitized</arm_group_label>
    <description>Collection of blood, stool, urin samples</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-Allergic</arm_group_label>
    <description>Collection of blood, stool, urin samples</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood, Stool, Urin samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Allergics and Non-Allergic subjects over 18 years.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  allergic and non-allergic volunteers&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients will not be considered for the study if they have co-morbidities such as&#xD;
             diabetes mellitus, disorders of the liver including hemochromatosis or kidney,&#xD;
             autoimmune or metabolic diseases and malignancy or if they use of medications (e.g.&#xD;
             antibiotics, PPIs) that influence the iron, inflammatory or microbial status. Further&#xD;
             exclusion criteria are pregnancy, lactation; veganism, zinc, and iron supplementation&#xD;
             and smoking. Volunteers will be asked to cease blood donation for at least three&#xD;
             months' before recruitment and to cease other supplements for at least two weeks, e.g.&#xD;
             vitamins, fish oil or minerals (other than zinc and iron).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Franziska Roth-Walter, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical University of Vienna</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medical University of Vienna</name>
      <address>
        <city>Vienna</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <reference>
    <citation>Roth-Walter F, Pacios LF, Bianchini R, Jensen-Jarolim E. Linking iron-deficiency with allergy: role of molecular allergens and the microbiome. Metallomics. 2017 Dec 1;9(12):1676-1692. doi: 10.1039/c7mt00241f. Epub 2017 Nov 9.</citation>
    <PMID>29120476</PMID>
  </reference>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>January 21, 2019</study_first_submitted>
  <study_first_submitted_qc>January 23, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 25, 2019</study_first_posted>
  <last_update_submitted>March 14, 2023</last_update_submitted>
  <last_update_submitted_qc>March 14, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Vienna</investigator_affiliation>
    <investigator_full_name>Franziska Roth-Walter</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>iron</keyword>
  <keyword>siderophores</keyword>
  <keyword>allergy</keyword>
  <keyword>allergic sensitisation</keyword>
  <keyword>trace elements</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypersensitivity</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03815981
org study id: 1972/2017
nct id: NCT03815981
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study aims to profile the siderophore-content in the human gut from allergic and
      non-allergic subjects and to assess their contribution in iron homeostasis.
Iron is an essential nutrient for the majority of commensal bacteria, which commonly secrete
      siderophores to liberate iron from their surroundings. In several studies, a misbalanced
      microbiota has been demonstrated in allergics suggesting that also their siderophore profile
      is severely attenuated.

      There are currently no data and very limited knowledge present on the composition of
      bacterial surviving factors in humans, or on their impact on the human immune system.

      As such, 1) the iron status, 2) the microbial biota composition and the 3)
      siderophore-profile in allergics and non-allergics will be assessed.
observational model: Cohort
time perspective: Cross-Sectional
measure: Iron status
time frame: baseline
description: Hemoglobin, Ferritin, hepcidin, iron and soluble transferrin receptor concentrations, transferrin saturation in %
measure: Siderophore profile
time frame: baseline
description: Mass spectrometric analysis of siderophores
arm group label: Allergic
description: Collection of blood, stool, urin samples
arm group label: Sensitized
description: Collection of blood, stool, urin samples
arm group label: Non-Allergic
description: Collection of blood, stool, urin samples
Blood, Stool, Urin samples
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Franziska Roth-Walter, PhD
role: Principal Investigator
affiliation: Medical University of Vienna
facility: 
country: Austria
citation: Roth-Walter F, Pacios LF, Bianchini R, Jensen-Jarolim E. Linking iron-deficiency with allergy: role of molecular allergens and the microbiome. Metallomics. 2017 Dec 1;9(12):1676-1692. doi: 10.1039/c7mt00241f. Epub 2017 Nov 9.
PMID: 29120476
responsible party type: Principal Investigator
investigator affiliation: Medical University of Vienna
investigator full name: Franziska Roth-Walter
investigator title: Principal Investigator
mesh term: Hypersensitivity
sharing ipd: Undecided