Microbiome and Mycobiome Registry of Volunteers With and... | NCT03819439

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

NCT03819439

Sponsor

University Hospitals Cleveland Medical Center

Status

Completed

Last Update Posted

Jul 30, 2019Actual

Enrollment

74Actual

Phase

Not provided

Conditions

Autism Spectrum Disorder

Interventions

Microbiome and Autism Questionnaire

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 30, 2019Actual

Primary Completion Date

Jul 23, 2019Actual

Completion Date

Jul 23, 2019Actual

First Submitted Date

Jan 15, 2019

First Submission Date that Met QC Criteria

Jan 24, 2019

First Posted Date

Jan 28, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 26, 2019

Last Update Posted Date

Jul 30, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mahmoiud A. Ghannoum, Director of Medical Mycology, University Hospitals Cleveland Medical CenterPrincipal Investigator

Lead Sponsor

University Hospitals Cleveland Medical CenterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Day

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

74Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Characterize the microbiome [bacteria and fungal community]	Identifying relative abundance of individual bacterial and fungal members.	10 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospitals Cleveland Medical Center		Cleveland	Ohio	44106	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000067877	Autism Spectrum Disorder
D001321	Autistic Disorder

Ancestor Terms

ID	Term
D002659	Child Development Disorders, Pervasive
D065886	Neurodevelopmental Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D064307	Microbiota

Ancestor Terms

ID	Term
D008827	Microbiological Phenomena
D058448	Biota
D044822	Biodiversity
D017753	Ecosystem

Browse Leaves

Not provided

Browse Branches

Not provided