Autism Spectrum DisorderNCT04869930
Establishing a Diagnostic and Therapeutic Index in Autism Spectrum Disorder (ASD) and Fragile X Syndrome
An observational study of Autism Spectrum Disorder and Fra(X) Syndrome, run by Nova Mentis Life Science Corp at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder, Fra(X) Syndrome
- What is being tested?
- specimen collection
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2021to May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- Early childhood (pre-diagnosis) OR existing ASD diagnosis (Moderate to Severe)
- Existing FXS diagnosis
Who cannot join
- Hospitalization
- Enrolled in another clinical study
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Broward Health Medical Center
Fort Lauderdale, Florida, 33316
Mikhail Mirer, MD
About this study
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
- Autism Spectrum Disorder, Fra(X) Syndrome
- Being tested
- specimen collection
- Medical subject headings
- Autism Spectrum Disorder, Fragile X Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
specimen collectionOther
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 group | Role | What they receive |
|---|---|---|
| Autism Spectrum Disorder (ASD) | Early childhood (pre-diagnosis) OR existing diagnosis of moderate/severe ASD Receives: Other: specimen collection | |
| Fragile X Syndrome (FXS) | Existing diagnosis of Fragile X Syndrome Receives: Other: specimen collection | |
| Healthy Controls | No diagnosed chronic conditions Receives: Other: specimen collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
microbial diversity profile
genetic analysis of microbial species in fecal samples
Measured: 2 years
Secondary outcomes (2)
differences in serotonin levels
molecular analysis of blood/urine/fecal samples
Measured: 2 years
differential expression of serotonin-related signaling molecules
genetic analysis of cheek swabs
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2021
- Study start1 Nov 2021 (estimated)
- Primary completionNov 2022 (estimated)
- Study completionMay 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nova Mentis Life Science Corp
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- FourthWall Testing
- Responsible party
- Sponsor
- Investigators
- Julia V Perederiy, PhD, Principal investigator, Nova Mentis Life Science Corp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04869930
- Sponsor's protocol ID
- NM101
- Status last verified
- Oct 2021
- First submitted
- 28 Apr 2021
- Last updated
- 13 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing a Diagnostic and Therapeutic Index in Autism Spectrum Disorder (ASD) and Fragile X Syndrome
- ClinicalTrials.gov ID
- NCT04869930
- Acronym / sponsor ID
- NM101
- Conditions
- Autism Spectrum Disorder, Fra(X) Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Nova Mentis Life Science CorpIndustry (pharma, biotech, devices)
- Collaborators
- FourthWall Testing
- Study start
- 1 Nov 2021 (estimated)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 3 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Autism Spectrum Disorder (ASD) | – | Other: specimen collectionEarly childhood (pre-diagnosis) OR existing diagnosis of moderate/severe ASD |
| Fragile X Syndrome (FXS) | – | Other: specimen collectionExisting diagnosis of Fragile X Syndrome |
| Healthy Controls | – | Other: specimen collectionNo diagnosed chronic conditions |
Who may qualify
- Ages
- 6 months to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (2 listed)
- Early childhood (pre-diagnosis) OR existing ASD diagnosis (Moderate to Severe)
- Existing FXS diagnosis
Key exclusion criteria (2 listed)
- Hospitalization
- Enrolled in another clinical study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| specimen collectionparticipants 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 | Other | Autism Spectrum Disorder (ASD), Fragile X Syndrome (FXS), Healthy Controls |
Primary outcome
microbial diversity profile
Time frame: 2 years
genetic analysis of microbial species in fecal samples
2 secondary outcomes
differences in serotonin levels
Time frame: 2 years
differential expression of serotonin-related signaling molecules
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julia V Perederiy, PhD principal investigator
Nova Mentis Life Science Corp
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism Spectrum Disorder and Fra(X) Syndrome, run by Nova Mentis Life Science Corp at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julia V Perederiy, PhD (888-505-NOVA, clinicaltrials@novamentis.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
microbial diversity profile (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2021.