Recruiting

Autism & Fragile X

Sponsor:

Nova Mentis Life Science Corp

Code:

NCT04869930

Conditions

Autism Spectrum Disorder

Fra(X) Syndrome

Eligibility Criteria

Sex: All

Age: 0 - 21

Healthy Volunteers: Accepted

Interventions

specimen collection

Study Details

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

Study ID

NCT04869930

Start date

Nov 1, 2021

Status verified date

Oct, 2021

Completion date

May, 2023

Anticipated

Primary completion date

Nov, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 21

Healthy Volunteers: Accepted

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

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Arms

Autism Spectrum Disorder (ASD)

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

Fragile X Syndrome (FXS)

Existing diagnosis of Fragile X Syndrome

Healthy Controls

No diagnosed chronic conditions

Interventions

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

Primary outcome measure

  • microbial diversity profile [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Julia V Perederiy, PhD

888-505-NOVAclinicaltrials@novamentis.ca

Locations

Broward Health Medical Center

Recruiting

Fort Lauderdale, Florida, United States, 33316

More Information

Sponsor

Nova Mentis Life Science Corp

Last update posted

Oct 13, 2021

Last verified

Oct, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Nova Mentis Life Science Corp on 2021-10-13.