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

NCT04869930 | Unknown

• 1 other identifier: NM101
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder; Fra(X) Syndrome

Outcome Measures

Primary Outcomes (1)

• microbial diversity profile

  genetic analysis of microbial species in fecal samples

  2 years

Secondary Outcomes (2)

• differences in serotonin levels

  2 years

• differential expression of serotonin-related signaling molecules

  2 years

Study Arms (3)

Autism Spectrum Disorder (ASD)

Early childhood (pre-diagnosis) OR existing diagnosis of moderate/severe ASD

Other: specimen collection

Fragile X Syndrome (FXS)

Existing diagnosis of Fragile X Syndrome

Other: specimen collection

Healthy Controls

No diagnosed chronic conditions

Other: specimen collection

Interventions

specimen collection OTHER

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

Autism Spectrum Disorder (ASD); Fragile X Syndrome (FXS); Healthy Controls

Eligibility Criteria

• Age: 6 Months - 21 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Autism Spectrum Disorder (ASD) and Fragile X Syndrome are neurodevelopmental disorders characterized by repetitive behavioral patterns, hypersensitivity, and persistent deficits in social communication. ASD is currently diagnosed exclusively on the basis of neurobehavioral patterning - an approach that (1) cannot distinguish subtle differences between ASD subtypes, (2) is subject to observer bias, and (3) introduces uncertainty regarding root causes and response to treatments. Developmental disorders are often accompanied by various co-occurring medical conditions like gastrointestinal dysfunction or anemia, which can be leveraged to sub-segment the autisms spectrum and improve diagnostics and treatment. Further investigation is needed to define the degree to which specific comorbidities contribute to behavioral symptomology.

You may qualify if:

• Early childhood (pre-diagnosis) OR existing ASD diagnosis (Moderate to Severe)
• Existing FXS diagnosis

You may not qualify if:

• Hospitalization
• Enrolled in another clinical study

Sponsors & Collaborators

• Nova Mentis Life Science Corp: lead
• FourthWall Testing: collaborator

Study Sites (1)

Broward Health Medical Center

Fort Lauderdale, Florida, 33316, United States

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder; Fragile X Syndrome

Interventions

Specimen Handling

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; X-Linked Intellectual Disability; Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Sex Chromosome Disorders; Chromosome Disorders; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn; Genetic Diseases, X-Linked; Heredodegenerative Disorders, Nervous System

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Julia V Perederiy, PhD

  Nova Mentis Life Science Corp

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julia V Perederiy, PhD

CONTACT

888-505-NOVA; clinicaltrials@novamentis.ca

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2021
• First Posted: May 3, 2021
• Study Start: November 1, 2021
• Primary Completion: November 1, 2022
• Study Completion: May 1, 2023
• Last Updated: October 13, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)