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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 : May 3, 2021
Sponsor:
Collaborators:
Microbiome Insights
FourthWall Testing
Information provided by (Responsible Party):
Nova Mentis Life Science Corp

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
Autism Spectrum Disorder Fra(X) Syndrome Other: specimen collection

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Study Type : Observational
Estimated 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
Estimated Study Start Date : May 3, 2021
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : December 2022


Group/Cohort 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




Primary Outcome Measures :
  1. microbial diversity profile [ Time Frame: 2 years ]
    genetic analysis of microbial species in fecal samples


Secondary Outcome Measures :
  1. differences in serotonin levels [ Time Frame: 2 years ]
    molecular analysis of blood/urine/fecal samples

  2. differential expression of serotonin-related signaling molecules [ Time Frame: 2 years ]
    genetic analysis of cheek swabs



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04869930


Contacts
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Contact: Julia V Perederiy, PhD 888-505-NOVA clinicaltrials@novamentis.ca

Locations
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United States, Florida
Broward Health Medical Center Recruiting
Fort Lauderdale, Florida, United States, 33316
Contact: Mikhail Mirer, MD         
Sponsors and Collaborators
Nova Mentis Life Science Corp
Microbiome Insights
FourthWall Testing
Investigators
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Principal Investigator: Julia V Perederiy, PhD Nova Mentis Life Science Corp
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Responsible Party: Nova Mentis Life Science Corp
ClinicalTrials.gov Identifier: NCT04869930    
Other Study ID Numbers: NM101
First Posted: May 3, 2021    Key Record Dates
Last Update Posted: May 3, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fragile X Syndrome
Syndrome
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Disease
Pathologic Processes
Neurodevelopmental Disorders
Mental Disorders
Mental Retardation, X-Linked
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Sex Chromosome Disorders
Chromosome Disorders
Congenital Abnormalities
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Heredodegenerative Disorders, Nervous System