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

NCT04869930 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2021-10-13

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • FourthWall Testing

    collaborator UNKNOWN
  • Nova Mentis Life Science Corp

    lead INDUSTRY

Principal Investigators

  • Julia V Perederiy, PhD · Nova Mentis Life Science Corp

Eligibility

Min Age
6 Months
Max Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-11-01
Primary Completion
2022-11-30
Completion
2023-05-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04869930 on ClinicalTrials.gov