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

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ClinicalTrials.gov Identifier: NCT04869930
Recruitment Status : Recruiting
First Posted : May 3, 2021
Last Update Posted : October 13, 2021
Sponsor:
Collaborator:
FourthWall Testing
Information provided by (Responsible Party):
Nova Mentis Life Science Corp

Tracking Information
First Submitted Date April 28, 2021
First Posted Date May 3, 2021
Last Update Posted Date October 13, 2021
Estimated Study Start Date November 1, 2021
Estimated Primary Completion Date November 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 28, 2021)
microbial diversity profile [ Time Frame: 2 years ]
genetic analysis of microbial species in fecal samples
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: April 28, 2021)
  • differences in serotonin levels [ Time Frame: 2 years ]
    molecular analysis of blood/urine/fecal samples
  • differential expression of serotonin-related signaling molecules [ Time Frame: 2 years ]
    genetic analysis of cheek swabs
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Establishing a Diagnostic and Therapeutic Index in Autism Spectrum Disorder (ASD) and Fragile X Syndrome
Official Title Establishing a Diagnostic and Therapeutic Index in Autism Spectrum Disorder (ASD) and Fragile X Syndrome
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 Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Autism Spectrum Disorder
  • Fra(X) Syndrome
Intervention 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
Study Groups/Cohorts
  • Autism Spectrum Disorder (ASD)
    Early childhood (pre-diagnosis) OR existing diagnosis of moderate/severe ASD
    Intervention: Other: specimen collection
  • Fragile X Syndrome (FXS)
    Existing diagnosis of Fragile X Syndrome
    Intervention: Other: specimen collection
  • Healthy Controls
    No diagnosed chronic conditions
    Intervention: Other: specimen collection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 28, 2021)
300
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 2023
Estimated Primary Completion Date November 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Hospitalization
  • Enrolled in another clinical study
Sex/Gender
Sexes Eligible for Study: All
Ages 6 Months to 21 Years   (Child, Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Julia V Perederiy, PhD 888-505-NOVA clinicaltrials@novamentis.ca
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04869930
Other Study ID Numbers NM101
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party Nova Mentis Life Science Corp
Original Responsible Party Same as current
Current Study Sponsor Nova Mentis Life Science Corp
Original Study Sponsor Same as current
Collaborators FourthWall Testing
Investigators
Principal Investigator: Julia V Perederiy, PhD Nova Mentis Life Science Corp
PRS Account Nova Mentis Life Science Corp
Verification Date October 2021