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

• Conditions: Fra(X) Syndrome; Autism Spectrum Disorder

• 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

Study Timeline

• Study First Submitted: 2021-04-28
• Study First Submitted QC: 2021-04-28
• Study First Posted: 2021-05-03
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-05
• Last Update Posted: 2021-10-13
• Study Start: 2021-11-01
• Primary Completion: 2022-11
• Study Completion: 2023-05

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

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