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OpenTrials
Completed

NCT Number: NCT03819439

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

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

Completed

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Key information

Age range

2 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Characterize the microbiome [bacteria and fungal community]

    Time frame: 10 years

    Identifying relative abundance of individual bacterial and fungal members.

Sponsors and collaborators

Lead sponsor

University Hospitals Cleveland Medical Center

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jan 28, 2019
Registry last updated
Jul 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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