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History of Changes for Study: NCT04869930
Establishing a Diagnostic and Therapeutic Index in Autism Spectrum Disorder (ASD) and Fragile X Syndrome
Latest version (submitted October 5, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 April 28, 2021 None (earliest Version on record)
2 October 5, 2021 Study Status and Sponsor/Collaborators
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Study NCT04869930
Submitted Date:  April 28, 2021 (v1)

Open or close this module Study Identification
Unique Protocol ID: NM101
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
Secondary IDs:
Open or close this module Study Status
Record Verification: April 2021
Overall Status: Recruiting
Study Start: May 3, 2021
Primary Completion: May 2022 [Anticipated]
Study Completion: December 2022 [Anticipated]
First Submitted: April 28, 2021
First Submitted that
Met QC Criteria:
April 28, 2021
First Posted: May 3, 2021 [Actual]
Last Update Submitted that
Met QC Criteria:
April 28, 2021
Last Update Posted: May 3, 2021 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Nova Mentis Life Science Corp
Responsible Party: Sponsor
Collaborators: Microbiome Insights
FourthWall Testing
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring:
Open or close this module 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.
Detailed Description:
Open or close this module Conditions
Conditions: Autism Spectrum Disorder
Fra(X) Syndrome
Keywords:
Open or close this module Study Design
Study Type: Observational
Observational Study Model: Case-Control
Time Perspective: Cross-Sectional
Biospecimen Retention:
Biospecimen Description:
Enrollment: 300 [Anticipated]
Number of Groups/Cohorts 3
Open or close this module Groups and Interventions
Groups/Cohorts Interventions
Autism Spectrum Disorder (ASD)
Early childhood (pre-diagnosis) OR existing diagnosis of moderate/severe ASD
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
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
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
Open or close this module Outcome Measures
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
Open or close this module Eligibility
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.
Sampling Method: Non-Probability Sample
Minimum Age: 6 Months
Maximum Age: 21 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
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
Open or close this module Contacts/Locations
Central Contact Person: Julia V Perederiy, PhD
Telephone: 888-505-NOVA
Email: clinicaltrials@novamentis.ca
Study Officials: Julia V Perederiy, PhD
Principal Investigator
Nova Mentis Life Science Corp
Locations: United States, Florida
Broward Health Medical Center
[Recruiting]
Fort Lauderdale, Florida, United States, 33316
Contact:Contact: Mikhail Mirer, MD
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

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