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

NCT04651972 | Unknown

• 1 other identifier: 2020PI116
• Study Type: observational
• Target: 140
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 2 Years - 14 Years
• Gender Eligibility Details: only males will be studied
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

urines

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Jean-Luc Olivier, MD, PhD,

  CHRU Nancy

  STUDY DIRECTOR

Central Study Contacts

Marc Merten, PhD

CONTACT

33 616 364 916; m.merten@chru-nancy.fr

Jean-Luc Olivier, MD, PhD, Pr

CONTACT

jl.olivier@chru-nancy.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 5, 2020
• First Posted: December 3, 2020
• Study Start: December 15, 2020
• Primary Completion: July 30, 2022
• Study Completion: July 30, 2022
• Last Updated: December 3, 2020

Record last verified: 2020-11