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

NCT03819439 | Completed

• 1 other identifier: 03/18/29
• Study Type: observational
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Autism Spectrum Disorder

Keywords

autism; microbiome; mycobiome; bacteria; fungi

Outcome Measures

Primary Outcomes (1)

• Characterize the microbiome [bacteria and fungal community]

  Identifying relative abundance of individual bacterial and fungal members.

  10 years

Interventions

Microbiome and Autism Questionnaire OTHER

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.

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Volunteers \< 2 years of age

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead

Study Sites (1)

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Biospecimen

Retention: NONE RETAINED

stool samples

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder

Interventions

Microbiota

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Microbiological Phenomena; Biota; Biodiversity; Ecosystem; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Medical Mycology

Study Record Dates

• First Submitted: January 15, 2019
• First Posted: January 28, 2019
• Study Start: January 30, 2019
• Primary Completion: July 23, 2019
• Study Completion: July 23, 2019
• Last Updated: July 30, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)