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CompletedNCT03819439Updated Jul 30, 2019

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

An observational study in Autism Spectrum Disorder, sponsored by University Hospitals Cleveland Medical Center. Completed at 1 site in United States. Open to participants aged 2 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-07-30.

Sponsored by University Hospitals Cleveland Medical Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
74
Ages
2 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Autism Spectrum Disorder

Keywords

  • autism
  • microbiome
  • mycobiome
  • bacteria
  • fungi
03

In context

Autistic Disorder

1,344 studies on the registry are indexed under Autistic Disorder; 334 are open to participants now.

This study's enrollment of 74 is below the median of 102 across 267 observational studies indexed under Autistic Disorder.

Browse Autistic Disorder studies →

Lead sponsor

University Hospitals Cleveland Medical Center is the lead sponsor of 283 studies on the registry; 42 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 29 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years and older
Sexes eligible
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.

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

Exclusion Criteria:

  • Volunteers \< 2 years of age
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
74 participants (actual)
Target follow-up
1 Day
Patient registry
Yes
Biospecimen retention
None retained

Interventions

  • OtherMicrobiome 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.

06

What researchers measure

Primary outcomes

  1. Characterize the microbiome [bacteria and fungal community]

    Identifying relative abundance of individual bacterial and fungal members.

    Time frame: 10 years

07

Study locations

1 site
  • University Hospitals Cleveland Medical Center
    Cleveland, Ohio 44106, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 30, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03819439
Lead sponsor
University Hospitals Cleveland Medical Center
Responsible party
Mahmoiud A. Ghannoum (Director of Medical Mycology, University Hospitals Cleveland Medical Center) — Principal investigator
First posted
Jan 28, 2019
Start date
Jan 30, 2019
Primary completion
Jul 23, 2019
Completion
Jul 23, 2019
Last update
Jul 30, 2019

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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