Clinical trial NCT05910424: Oral Microbiota and Oral Status of Adult Patients With Autism Spectrum Disorders (MICAA: MICrobiota Autism Adults)
Official title: Characterisation of the Oral Microbiota and Oral Status of a Population of Adult Patients With Autism Spectrum Disorders: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: Autism Spectrum Disorder
Oral microbiota
Oral Health
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2023-06-18
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pilot study concerning adults with autism spectrum disorder
Primary purpose: DIAGNOSTIC

Brief summary: The goals of this pilot study are to assess the presence of harmful germs for gums and to assess oral health in adults with autism spectrum disorder.

Detailed description: Participants or their tutors will fulfill a form with general health information and daily habits.

Investigators will :

* collect saliva, gum fluid and/ or dental plaque to characterise germs
* assess gum health and oral hygiene
* register decays, filled and missing teeth.

Eligibility criteria: Inclusion Criteria:

* A person (or legal representative) who has received full information about the organisation of the research and accept to participate and the use of his or her data.
* Adult with autism spectrum disorder, men or women aged between 18 and 60.
* Member of a social security scheme or beneficiary of a medical insurance

Exclusion Criteria:

* Children under 18 with autism spectrum disorder
* Use of medication or situations that may affect the microbiota (use of antibiotics, probiotics, steroidal or non-steroidal anti-inflammatory drugs in the last 3 months, strict mouth breathing)
* Smoking
* Very lingual position of the teeth hindering clinical assessment of the periodontium
* Patients who have had periodontal treatment for less than 6 months
* Persons covered by articles L. 1121-5 to L. 1121-7 and L1122-2 of the French Public Health Code:
* Pregnant women, women in labour or breast-feeding mothers
* Persons deprived of their liberty by a judicial or administrative decision
* Persons unable to give their consent
* Person under psychiatric care by virtue of articles L. 3212-1 and L. 3213-1 of the Public Health Code
* Minor (not emancipated)

Primary outcomes:
measure: Presence of periodontopathogenic bacteria (harmful for gums)
timeFrame: Collection on Day 1
Secondary outcomes:
measure: Assessment of the presence of parasites Entamoeba gingivalis subtype 1 (ST1) and subtype 2 (ST2) and Trichomonas tenax
timeFrame: Collection on Day 1
measure: Assessment of the periodontal status of patients with Autism Spectrum Disorder
timeFrame: Day 1
measure: Assessment of the dental condition
timeFrame: Day 1
measure: Assessment of oral hygiene
timeFrame: Day 1
measure: Collection of data about lifestyle habits (oral and dental hygiene, diet, activity, etc.) and drug treatments that may influence the clinical parameters observed
timeFrame: Before samples collection and clinical examination
Other outcomes:
Locations:
city: Vandœuvre-lès-Nancy
country: France
facility: CHRU Brabois
Study officials:
affiliation: CHRU Nancy
name: Ludivine BERBE
role: PRINCIPAL_INVESTIGATOR
References: