Measurement of vanilloïd Compounds in Urin of Autistic vs Control Patients, as Potential Biomarkers

Autism Spectrum Disorder Clinical Trial

— DIADAUVEDA  

Official title:

Diagnostic of Autism by Measurement of vanilloïd Compounds in Urin

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04651972
• Other study ID #: 2020PI116
• Status: Not yet recruiting
• Start date: December 15, 2020
• Est. completion date: July 30, 2022

Study information

• Verified date: November 2020
• Source: Central Hospital, Nancy, France
• Contact: Marc Merten, PhD
• Phone: 33 616 364 916
• Email: m.merten[@]chru-nancy.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 140
• Est. completion date: July 30, 2022
• Est. primary completion date: July 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 2 Years to 14 Years

Eligibility

Inclusion criteria :

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

Exclusion criteria

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

Related Conditions & MeSH terms

• Autism Spectrum Disorder

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	through study completion, an average of 18 months