Autism Spectrum Disorder, Fra(X) Syndrome
Conditions
Brief summary
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.
Interventions
OTHERspecimen 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
Sponsors
FourthWall Testing
Nova Mentis Life Science Corp
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
6 Months to 21 Years
Healthy volunteers
Yes
Inclusion criteria
* Early childhood (pre-diagnosis) OR existing ASD diagnosis (Moderate to Severe) * Existing FXS diagnosis
Exclusion criteria
* Hospitalization * Enrolled in another clinical study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| microbial diversity profile | 2 years | genetic analysis of microbial species in fecal samples |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| differences in serotonin levels | 2 years | molecular analysis of blood/urine/fecal samples |
| differential expression of serotonin-related signaling molecules | 2 years | genetic analysis of cheek swabs |
Countries
United States
Contacts
Primary ContactJulia V Perederiy, PhD
Outcome results
None listed