Oral Microbiota and Oral Status of Adult Patients With Autism Spectrum Disorders (MICAA: MICrobiota Autism Adults)

NCT05910424 | Completed

• 1 other identifier: 2023-A01024-41
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder

Keywords

Autism Spectrum Disorder; Oral microbiota; Oral Health

Outcome Measures

Primary Outcomes (1)

• Presence of periodontopathogenic bacteria (harmful for gums)

  Technique used = Polymerase Chain Reaction (PCR) Measure unit = Colony-Forming Unit (CFU)

  Collection on Day 1

Secondary Outcomes (5)

• Assessment of the presence of parasites Entamoeba gingivalis subtype 1 (ST1) and subtype 2 (ST2) and Trichomonas tenax

  Collection on Day 1

• Assessment of the periodontal status of patients with Autism Spectrum Disorder

  Day 1

• Assessment of the dental condition

  Day 1

• Assessment of oral hygiene

  Day 1

• Collection of data about lifestyle habits (oral and dental hygiene, diet, activity, etc.) and drug treatments that may influence the clinical parameters observed

  Before samples collection and clinical examination

Study Arms (1)

Adults with Autism Spectrum Disorder

EXPERIMENTAL

* Adults with autism spectrum disorder * Aged between 18 and 60 years old * Dental cares and follow-up in Nancy hospital

Other: collection of saliva, gum fluid and/or dental plaque samples

Interventions

collection of saliva, gum fluid and/or dental plaque samples OTHER

Non-invasive sampling of dental plaque, crevicular fluid and/or saliva, using an examination probe, paper tips and saliva swabs

Adults with Autism Spectrum Disorder

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

CHRU Brabois

Vandœuvre-lès-Nancy, 54500, France

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Ludivine BERBE

  CHRU Nancy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No Treatment
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dentist, University Hospital Assistant

Model Details: Pilot study concerning adults with autism spectrum disorder

Study Record Dates

• First Submitted: June 7, 2023
• First Posted: June 18, 2023
• Study Start: November 22, 2023
• Primary Completion: April 9, 2024
• Study Completion: April 30, 2024
• Last Updated: August 26, 2024

Record last verified: 2024-08

Locations

FR (1)