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

Sponsor
Nova Mentis Life Science Corp (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04869930
Collaborator
FourthWall Testing (Other)
300
Enrollment
1
Location
17.9
Anticipated Duration (Months)
16.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: specimen collection

Study Design

Study Type:
Observational
Anticipated Enrollment :
300 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
Establishing a Diagnostic and Therapeutic Index in Autism Spectrum Disorder (ASD) and Fragile X Syndrome
Anticipated Study Start Date :
Nov 1, 2021
Anticipated Primary Completion Date :
Nov 1, 2022
Anticipated Study Completion Date :
May 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Autism Spectrum Disorder (ASD)

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

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
Fragile X Syndrome (FXS)

Existing diagnosis of Fragile X Syndrome

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
Healthy Controls

No diagnosed chronic conditions

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

Outcome Measures

Primary Outcome Measures

  1. microbial diversity profile [2 years]

    genetic analysis of microbial species in fecal samples

Secondary Outcome Measures

  1. differences in serotonin levels [2 years]

    molecular analysis of blood/urine/fecal samples

  2. differential expression of serotonin-related signaling molecules [2 years]

    genetic analysis of cheek swabs

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Months to 21 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

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

  • Existing FXS diagnosis

Exclusion Criteria:

  • Hospitalization

  • Enrolled in another clinical study

Contacts and Locations

Locations

Site City State Country Postal Code
1 Broward Health Medical Center Fort Lauderdale Florida United States 33316

Sponsors and Collaborators

  • Nova Mentis Life Science Corp
  • FourthWall Testing

Investigators

  • Principal Investigator: Julia V Perederiy, PhD, Nova Mentis Life Science Corp

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nova Mentis Life Science Corp
ClinicalTrials.gov Identifier:
NCT04869930
Other Study ID Numbers:
  • NM101
First Posted:
May 3, 2021
Last Update Posted:
Oct 13, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Fragile X Syndrome
Syndrome
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive

Study Results

No Results Posted as of Oct 13, 2021