Establishing a Diagnostic and Therapeutic Index in Autism Spectrum Disorder (ASD) and Fragile X Syndrome

Autism Spectrum Disorder Clinical Trial

Official title:

Establishing a Diagnostic and Therapeutic Index in Autism Spectrum Disorder (ASD) and Fragile X Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04869930
• Other study ID #: NM101
• Status: Recruiting
• Start date: November 1, 2021
• Est. completion date: May 2023

Study information

• Verified date: October 2021
• Source: Nova Mentis Life Science Corp
• Contact: Julia V Perederiy, PhD
• Phone: 888-505-NOVA
• Email: clinicaltrials[@]novamentis.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive
• Fra(X) Syndrome
• Fragile X Syndrome
• Syndrome

Intervention

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

Locations

Country	Name	City	State
United States	Broward Health Medical Center	Fort Lauderdale	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Nova Mentis Life Science Corp	FourthWall Testing

Country where clinical trial is conducted

United States, 

Outcome

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