<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/NCT03819439</url>
  </required_header>
  <id_info>
    <org_study_id>03/18/29</org_study_id>
    <nct_id>NCT03819439</nct_id>
  </id_info>
  <brief_title>Microbiome and Mycobiome Registry of Volunteers With and Without Autism Spectrum Disorder</brief_title>
  <official_title>Microbiome and Mycobiome Registry of Volunteers With and Without Autism Spectrum Disorder</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospitals Cleveland Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospitals Cleveland Medical Center</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Analyze, describe, and understand how the human gut microbiome (i.e. bacteriome and&#xD;
      mycobiome) and Autism Spectrum Disorder (ASD) are related.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 30, 2019</start_date>
  <completion_date type="Actual">July 23, 2019</completion_date>
  <primary_completion_date type="Actual">July 23, 2019</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>1 Day</target_duration>
  <primary_outcome>
    <measure>Characterize the microbiome [bacteria and fungal community]</measure>
    <time_frame>10 years</time_frame>
    <description>Identifying relative abundance of individual bacterial and fungal members.</description>
  </primary_outcome>
  <enrollment type="Actual">74</enrollment>
  <condition>Autism Spectrum Disorder</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Microbiome and Autism Questionnaire</intervention_name>
    <description>The questionnaire will be administered to collect demographic data (i.e. sex, age, race, and ethnicity) of the volunteers. Additionally, it will ask for the volunteers to identify whether or not they have autism spectrum disorder and what other medical conditions they have and what medications (e.g. prescribed, over the counter, herbal; etc.) that they take.</description>
  </intervention>
  <biospec_retention>None Retained</biospec_retention>
  <biospec_descr>
    <textblock>
      stool samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Volunteers will or will not have a diagnosis of Autism Spectrum Disorder (ASD). Volunteers&#xD;
        will be both local and national. There will be no limit to the number of volunteers who&#xD;
        participate; however, we anticipate being able to enroll at least 50 volunteers within the&#xD;
        first year.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Volunteers &gt; 2 years of age&#xD;
&#xD;
          -  Able to list all medical conditions and medications when applicable.&#xD;
&#xD;
          -  Have already donated a stool sample to BIOHM™.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Volunteers &lt; 2 years of age&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University Hospitals Cleveland Medical Center</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>January 15, 2019</study_first_submitted>
  <study_first_submitted_qc>January 24, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 28, 2019</study_first_posted>
  <last_update_submitted>July 26, 2019</last_update_submitted>
  <last_update_submitted_qc>July 26, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 30, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospitals Cleveland Medical Center</investigator_affiliation>
    <investigator_full_name>Mahmoiud A. Ghannoum</investigator_full_name>
    <investigator_title>Director of Medical Mycology</investigator_title>
  </responsible_party>
  <keyword>autism</keyword>
  <keyword>microbiome</keyword>
  <keyword>mycobiome</keyword>
  <keyword>bacteria</keyword>
  <keyword>fungi</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Autistic Disorder</mesh_term>
    <mesh_term>Autism Spectrum Disorder</mesh_term>
    <mesh_term>Child Development Disorders, Pervasive</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/NCT03819439
org study id: 03/18/29
nct id: NCT03819439
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Analyze, describe, and understand how the human gut microbiome (i.e. bacteriome and
      mycobiome) and Autism Spectrum Disorder (ASD) are related.
observational model: Cohort
time perspective: Prospective
measure: Characterize the microbiome [bacteria and fungal community]
time frame: 10 years
description: Identifying relative abundance of individual bacterial and fungal members.
intervention type: Other
intervention name: Microbiome and Autism Questionnaire
description: The questionnaire will be administered to collect demographic data (i.e. sex, age, race, and ethnicity) of the volunteers. Additionally, it will ask for the volunteers to identify whether or not they have autism spectrum disorder and what other medical conditions they have and what medications (e.g. prescribed, over the counter, herbal; etc.) that they take.
stool samples
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 2 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University Hospitals Cleveland Medical Center
investigator full name: Mahmoiud A. Ghannoum
investigator title: Director of Medical Mycology
mesh term: Autistic Disorder
mesh term: Autism Spectrum Disorder
mesh term: Child Development Disorders, Pervasive
sharing ipd: No