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

Nova Mentis Life Science

Status: Unknown

Conditions: Autism Spectrum Disorder; Fra(X) Syndrome

Treatments: Other: specimen collection

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT04869930

NM101

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 6 months to 21 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Hospitalization
• Enrolled in another clinical study

Trial design

300 participants in 3 patient groups

Autism Spectrum Disorder (ASD)

Description:

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

Treatment:

Other: specimen collection

Fragile X Syndrome (FXS)

Description:

Existing diagnosis of Fragile X Syndrome

Treatment:

Other: specimen collection

Healthy Controls

Description:

No diagnosed chronic conditions

Treatment:

Other: specimen collection