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| Name | Class |
|---|---|
| FourthWall Testing | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autism Spectrum Disorder (ASD) | Early childhood (pre-diagnosis) OR existing diagnosis of moderate/severe ASD |
| |
| Fragile X Syndrome (FXS) | Existing diagnosis of Fragile X Syndrome |
| |
| Healthy Controls | No diagnosed chronic conditions |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| specimen collection | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| microbial diversity profile | genetic analysis of microbial species in fecal samples | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| differences in serotonin levels | molecular analysis of blood/urine/fecal samples | 2 years |
| differential expression of serotonin-related signaling molecules | genetic analysis of cheek swabs |
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Exclusion Criteria:
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Autism Spectrum Disorder (ASD) and Fragile X Syndrome are neurodevelopmental disorders characterized by repetitive behavioral patterns, hypersensitivity, and persistent deficits in social communication. ASD is currently diagnosed exclusively on the basis of neurobehavioral patterning - an approach that (1) cannot distinguish subtle differences between ASD subtypes, (2) is subject to observer bias, and (3) introduces uncertainty regarding root causes and response to treatments. Developmental disorders are often accompanied by various co-occurring medical conditions like gastrointestinal dysfunction or anemia, which can be leveraged to sub-segment the autisms spectrum and improve diagnostics and treatment. Further investigation is needed to define the degree to which specific comorbidities contribute to behavioral symptomology.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Julia V Perederiy, PhD | Contact | 888-505-NOVA | clinicaltrials@novamentis.ca |
| Name | Affiliation | Role |
|---|---|---|
| Julia V Perederiy, PhD | Nova Mentis Life Science Corp | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Broward Health Medical Center | Recruiting | Fort Lauderdale | Florida | 33316 | United States |
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D005600 | Fragile X Syndrome |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D038901 | X-Linked Intellectual Disability |
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| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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| 2 years |
| D008607 | Intellectual Disability |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D025064 | Sex Chromosome Disorders |
| D025063 | Chromosome Disorders |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D030342 | Genetic Diseases, Inborn |
| D040181 | Genetic Diseases, X-Linked |
| D020271 | Heredodegenerative Disorders, Nervous System |