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 : Unknown
Verified October 2021 by Nova Mentis Life Science Corp.
Recruitment status was: Recruiting
First Posted : May 3, 2021
Last Update Posted : October 13, 2021
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Condition or disease | Intervention/treatment |
---|---|
Autism Spectrum Disorder Fra(X) Syndrome | Other: specimen collection |
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 : | November 1, 2021 |
Estimated Primary Completion Date : | November 2022 |
Estimated Study Completion Date : | May 2023 |
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 |
- microbial diversity profile [ Time Frame: 2 years ]genetic analysis of microbial species in fecal samples
- 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
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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 |
Inclusion Criteria:
- Early childhood (pre-diagnosis) OR existing ASD diagnosis (Moderate to Severe)
- Existing FXS diagnosis
Exclusion Criteria:
- Hospitalization
- Enrolled in another clinical study
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
Contact: Julia V Perederiy, PhD | 888-505-NOVA | clinicaltrials@novamentis.ca |
United States, Florida | |
Broward Health Medical Center | Recruiting |
Fort Lauderdale, Florida, United States, 33316 | |
Contact: Mikhail Mirer, MD |
Principal Investigator: | Julia V Perederiy, PhD | Nova Mentis Life Science Corp |
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: | October 13, 2021 |
Last Verified: | October 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
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 |