Autism Spectrum DisorderDIADAUVEDANCT04651972
Measurement of vanilloïd Compounds in Urin of Autistic vs Control Patients, as Potential Biomarkers
An observational study of Autism Spectrum Disorder, run by Central Hospital, Nancy, France.
Trial summary
In a former study, four vanilloid compounds were observed increased in the urin of autistic patients. The present study is aimed at performing a ambispective study to confirm or not these preliminary results. Read more about this study
- Who is it for?
- Ages 2 to 14 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2020to 30 Jul 2022
- 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 2 to 14 years
- Men only
- Healthy volunteers accepted
- Child
Study population: Autistic children according to CM-10 (F84.0)
Who may be able to join
- For cases :
- Male children aged 2 years to less than 15 years inclusive years at time of sample collection
- Children with a diagnosis of autism (ICD-10 F84.0) after assessment by a child psychiatrist.
- For healthy chlidren:
- Children aged 2 years to less than 15 years old performing an ECBU at the CHRU of Nancy as part of their care.
- Patient whose ECBU is negative with respect to cytobacteriology (absence of urinary infection).
- Child can be matched to a CAS
Who cannot join
- For cases:
- Children in whom one of the following pathologies is found during the anamnesis or in the clinical record : (i) renal insufficiency; (ii) urinary tract infection at the time of sampling and/or metabolic disease
- Children on antibiotic treatment at the time of collection
- For healthy chlidren :
- children whose urine culture come from one of the following departments: Pediatric Nephrology (potential risk of renal failure) or Pediatric Neurology (potential risk of neurological disorder).
- with a diagnosis of autism
- with a metabolic disease
- children undergoing antibiotic treatment at the time of collectio
Trial locations and contacts
No sites are listed yet.
Jean-Luc Olivier, MD, PhD, Pr contact
About this study
Official title: Diagnostic of Autism by Measurement of vanilloïd Compounds in Urin
In a former study, four vanilloid compounds were observed increased in the urin of autistic patients. The present study is aimed at performing a ambispective study to confirm or not these preliminary results. 70 urins from autistic children (already collected) will be compared to 70 urins of non autistic children (collected without intervention, remaining sample from the standard care), in terms of measurements of four vanilloid compounds using a GCMS apparatus.
- Conditions
- Autism Spectrum Disorder
- Medical subject headings
- Autism Spectrum Disorder
What is being measured
The primary outcome is the main question the study is designed to answer.
measurements of vanilloid compound in urins
The primary end point is to determine if isolated or combinations of vanilloid compound measured in urin, may discriminate autistic vs non autistic childen
Measured: through study completion, an average of 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2020
- Study start15 Dec 2020 (estimated)
- Primary completion30 Jul 2022 (estimated)
- Study completion30 Jul 2022 (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.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- 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
- Other
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marc MERTEN, Central Hospital, Nancy, France
- Investigators
- Jean-Luc Olivier, MD, PhD,, Study director, CHRU Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04651972
- Sponsor's protocol ID
- 2020PI116
- Acronym
- DIADAUVEDA
- Status last verified
- Nov 2020
- First submitted
- 5 Oct 2020
- Last updated
- 3 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic of Autism by Measurement of vanilloïd Compounds in Urin
- ClinicalTrials.gov ID
- NCT04651972
- Acronym / sponsor ID
- DIADAUVEDA / 2020PI116
- Conditions
- Autism Spectrum Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 15 Dec 2020 (estimated)
- Primary completion
- 30 Jul 2022 (estimated)
- Study completion
- 30 Jul 2022 (estimated)
- First posted
- 3 Dec 2020 (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.
In a former study, four vanilloid compounds were observed increased in the urin of autistic patients. The present study is aimed at performing a ambispective study to confirm or not these preliminary results. 70 urins from autistic children (already collected) will be compared to 70 urins of non autistic children (collected without intervention, remaining sample from the standard care), in terms of measurements of four vanilloid compounds using a GCMS apparatus.
Study design
- Observational model
- Case-control
- Time perspective
- Other
Who may qualify
- Ages
- 2 to 14 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Autistic children according to CM-10 (F84.0)
Key inclusion criteria (7 listed)
- Male children aged 2 years to less than 15 years inclusive years at time of sample collection
- Children with a diagnosis of autism (ICD-10 F84.0) after assessment by a child psychiatrist.
- Children aged 2 years to less than 15 years old performing an ECBU at the CHRU of Nancy as part of their care.
- Patient whose ECBU is negative with respect to cytobacteriology (absence of urinary infection).
- Child can be matched to a CAS
Key exclusion criteria (8 listed)
- Children in whom one of the following pathologies is found during the anamnesis or in the clinical record : (i) renal insufficiency; (ii) urinary tract infection at the time of sampling and/or metabolic disease
- Children on antibiotic treatment at the time of collection
- children whose urine culture come from one of the following departments: Pediatric Nephrology (potential risk of renal failure) or Pediatric Neurology (potential risk of neurological disorder).
- with a diagnosis of autism
- with a metabolic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
measurements of vanilloid compound in urins
Time frame: through study completion, an average of 18 months
The primary end point is to determine if isolated or combinations of vanilloid compound measured in urin, may discriminate autistic vs non autistic childen
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2020.
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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.
Jean-Luc Olivier, MD, PhD, Pr contact
Jean-Luc Olivier, MD, PhD, study director
CHRU Nancy
Questions about this trial
What is this clinical trial studying?
An observational study of Autism Spectrum Disorder, run by Central Hospital, Nancy, France.
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 7 inclusion and 8 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 3 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
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 Marc Merten, PhD (33 616 364 916, m.merten@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measurements of vanilloid compound in urins (time frame: through study completion, an average of 18 months). 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 3 Dec 2020.