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Microbiome and Mycobiome Registry of Volunteers With and Without Autism Spectrum Disorder

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ClinicalTrials.gov Identifier: NCT03819439
Recruitment Status : Recruiting
First Posted : January 28, 2019
Last Update Posted : January 29, 2019
Sponsor:
Information provided by (Responsible Party):
Mahmoiud A. Ghannoum, University Hospitals Cleveland Medical Center

Brief Summary:
Analyze, describe, and understand how the human gut microbiome (i.e. bacteriome and mycobiome) and Autism Spectrum Disorder (ASD) are related.

Condition or disease Intervention/treatment
Autism Spectrum Disorder Other: Microbiome and Autism Questionnaire

Study Type : Observational [Patient Registry]
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Official Title: Microbiome and Mycobiome Registry of Volunteers With and Without Autism Spectrum Disorder
Estimated Study Start Date : January 30, 2019
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: Microbiome and Autism Questionnaire
    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.


Primary Outcome Measures :
  1. Characterize the microbiome [bacteria and fungal community] [ Time Frame: 10 years ]
    Identifying relative abundance of individual bacterial and fungal members.



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Volunteers will or will not have a diagnosis of Autism Spectrum Disorder (ASD). Volunteers will be both local and national. There will be no limit to the number of volunteers who participate; however, we anticipate being able to enroll at least 50 volunteers within the first year.
Criteria

Inclusion Criteria:

  • Volunteers > 2 years of age
  • Able to list all medical conditions and medications when applicable.
  • Have already donated a stool sample to BIOHM™.

Exclusion Criteria:

  • Volunteers < 2 years of age

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03819439


Contacts
Contact: Mahmoud A Ghannoum, PhD 216-905-5880 Mahmoud.Ghannoum@UHhospitals.org
Contact: Mary Consolo 216-844-7834 Mary.Consolo@UHhospitals.org

Locations
United States, Ohio
University Hospitals Cleveland Medical Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: Mahmoud Ghannoum, PhD         
Sponsors and Collaborators
University Hospitals Cleveland Medical Center

Additional Information:

Responsible Party: Mahmoiud A. Ghannoum, Director of Medical Mycology, University Hospitals Cleveland Medical Center
ClinicalTrials.gov Identifier: NCT03819439     History of Changes
Other Study ID Numbers: 03/18/29
First Posted: January 28, 2019    Key Record Dates
Last Update Posted: January 29, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mahmoiud A. Ghannoum, University Hospitals Cleveland Medical Center:
autism
microbiome
mycobiome
bacteria
fungi

Additional relevant MeSH terms:
Disease
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Pathologic Processes
Neurodevelopmental Disorders
Mental Disorders