Autism Spectrum Disorder Clinical Trial
Official title:
Establishing a Diagnostic and Therapeutic Index in Autism Spectrum Disorder (ASD) and Fragile X Syndrome
NCT number | NCT04869930 |
Other study ID # | NM101 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | November 1, 2021 |
Est. completion date | May 2023 |
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.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | May 2023 |
Est. primary completion date | November 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 6 Months to 21 Years |
Eligibility | Inclusion Criteria: - Early childhood (pre-diagnosis) OR existing ASD diagnosis (Moderate to Severe) - Existing FXS diagnosis Exclusion Criteria: - Hospitalization - Enrolled in another clinical study |
Country | Name | City | State |
---|---|---|---|
United States | Broward Health Medical Center | Fort Lauderdale | Florida |
Lead Sponsor | Collaborator |
---|---|
Nova Mentis Life Science Corp | FourthWall Testing |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | microbial diversity profile | genetic analysis of microbial species in fecal samples | 2 years | |
Secondary | differences in serotonin levels | molecular analysis of blood/urine/fecal samples | 2 years | |
Secondary | differential expression of serotonin-related signaling molecules | genetic analysis of cheek swabs | 2 years |
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