Establishing a Diagnostic and Therapeutic Index in Autism Spectrum Disorder (ASD) and Fragile X Syndrome
- Conditions
- Fra(X) SyndromeAutism Spectrum Disorder
- Interventions
- Other: specimen collection
- Registration Number
- NCT04869930
- Lead Sponsor
- Nova Mentis Life Science Corp
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 300
Inclusion Criteria
- Early childhood (pre-diagnosis) OR existing ASD diagnosis (Moderate to Severe)
- Existing FXS diagnosis
Exclusion Criteria
- Hospitalization
- Enrolled in another clinical study
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Autism Spectrum Disorder (ASD) specimen collection Early childhood (pre-diagnosis) OR existing diagnosis of moderate/severe ASD Fragile X Syndrome (FXS) specimen collection Existing diagnosis of Fragile X Syndrome Healthy Controls specimen collection No diagnosed chronic conditions
- Primary Outcome Measures
Name Time Method microbial diversity profile 2 years genetic analysis of microbial species in fecal samples
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Broward Health Medical Center
🇺🇸Fort Lauderdale, Florida, United States