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Establishing a Diagnostic and Therapeutic Index in Autism Spectrum Disorder (ASD) and Fragile X Syndrome

NCT ID: NCT04869930

Last Updated: 2021-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-01

Study Completion Date

2023-05-31

Brief Summary

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The purpose of this study is to accumulate and quantitatively analyze data on the microbiome, serotonin signaling and genetics, and inflammatory cytokines from patients with Autism Spectrum Disorder and Fragile X Syndrome. Computational analysis of multi-dimensional datasets will be used to establish a "Diagnostic and Therapeutic Index" - an objective set of tools that can help differentiate subtypes of Autism Spectrum Disorder and develop more accurate methods of diagnosis and response to treatment.

Detailed Description

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Conditions

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Autism Spectrum Disorder Fra(X) Syndrome

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Autism Spectrum Disorder (ASD)

Early childhood (pre-diagnosis) OR existing diagnosis of moderate/severe ASD

specimen collection

Intervention Type OTHER

participants will submit at minimum two of four required samples: fecal, urine, finger/toe-prick blood, and cheek swab, collected at home via commercially available kits

Fragile X Syndrome (FXS)

Existing diagnosis of Fragile X Syndrome

specimen collection

Intervention Type OTHER

participants will submit at minimum two of four required samples: fecal, urine, finger/toe-prick blood, and cheek swab, collected at home via commercially available kits

Healthy Controls

No diagnosed chronic conditions

specimen collection

Intervention Type OTHER

participants will submit at minimum two of four required samples: fecal, urine, finger/toe-prick blood, and cheek swab, collected at home via commercially available kits

Interventions

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specimen collection

participants will submit at minimum two of four required samples: fecal, urine, finger/toe-prick blood, and cheek swab, collected at home via commercially available kits

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Early childhood (pre-diagnosis) OR existing ASD diagnosis (Moderate to Severe)
* Existing FXS diagnosis

Exclusion Criteria

* Hospitalization
* Enrolled in another clinical study
Minimum Eligible Age

6 Months

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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FourthWall Testing

UNKNOWN

Sponsor Role collaborator

Nova Mentis Life Science Corp

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Julia V Perederiy, PhD

Role: PRINCIPAL_INVESTIGATOR

Nova Mentis Life Science Corp

Locations

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Broward Health Medical Center

Fort Lauderdale, Florida, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Julia V Perederiy, PhD

Role: CONTACT

[email protected]
888-505-NOVA

Facility Contacts

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Mikhail Mirer, MD

Role: primary

Other Identifiers

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NM101

Identifier Type: -

Identifier Source: org_study_id