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

Autism Spectrum Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03819439
• Other study ID #: 03/18/29
• Status: Completed
• Start date: January 30, 2019
• Est. completion date: July 23, 2019

Study information

• Verified date: July 2019
• Source: University Hospitals Cleveland Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: July 23, 2019
• Est. primary completion date: July 23, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive
• Disease

Intervention

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.

Locations

Country	Name	City	State
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
University Hospitals Cleveland Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Characterize the microbiome [bacteria and fungal community]	Identifying relative abundance of individual bacterial and fungal members.	10 years