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

NCT ID: NCT04651972

Last Updated: 2020-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

140 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-15

Study Completion Date

2022-07-30

Brief Summary

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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.

Detailed Description

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Conditions

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Autism Spectrum Disorder

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

OTHER

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Maximum Eligible Age

14 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

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Marc MERTEN

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jean-Luc Olivier, MD, PhD,

Role: STUDY_DIRECTOR

CHRU Nancy

Central Contacts

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Marc Merten, PhD

Role: CONTACT

Phone: 33 616 364 916

Email: [email protected]

Jean-Luc Olivier, MD, PhD, Pr

Role: CONTACT

Email: [email protected]

Other Identifiers

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2020PI116

Identifier Type: -

Identifier Source: org_study_id