Trials / Unknown
UnknownNCT04869930
Establishing a Diagnostic and Therapeutic Index in Autism Spectrum Disorder (ASD) and Fragile X Syndrome
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 300 (estimated)
- Sponsor
- Nova Mentis Life Science Corp · Industry
- Sex
- All
- Age
- 6 Months – 21 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | 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 |
Timeline
- Start date
- 2021-11-01
- Primary completion
- 2022-11-01
- Completion
- 2023-05-01
- First posted
- 2021-05-03
- Last updated
- 2021-10-13
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT04869930. Inclusion in this directory is not an endorsement.