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

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.

Study Overview

• Status: Unknown
• Conditions: Autism Spectrum Disorder

• Study Type: Observational
• Enrollment (Anticipated): 140

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 14 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

Autistic children according to CM-10 (F84.0)

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France
• Investigators: Study Director: Jean-Luc Olivier, MD, PhD,, Chru Nancy

Study record dates

Study Major Dates

• Study Start (Anticipated): December 15, 2020
• Primary Completion (Anticipated): July 30, 2022
• Study Completion (Anticipated): July 30, 2022

Study Registration Dates

• First Submitted: October 5, 2020
• First Submitted That Met QC Criteria: November 26, 2020
• First Posted (Actual): December 3, 2020

Study Record Updates

• Last Update Posted (Actual): December 3, 2020
• Last Update Submitted That Met QC Criteria: November 26, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder
• Other Study ID Numbers: 2020PI116

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No