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

Characterisation of the Oral Microbiota and Oral Status of a Population of Adult Patients With Autism Spectrum Disorders: a Pilot Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Autism Spectrum Disorder
• Intervention / Treatment: Other: collection of saliva, gum fluid and/or dental plaque samples

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ludivine BERBE; Phone Number: 0033383154256; Email: ludivine.berbe@univ-lorraine.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Adults with Autism Spectrum Disorder; 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; Non-invasive sampling of dental plaque, crevicular fluid and/or saliva, using an examination probe, paper tips and saliva swabs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of periodontopathogenic bacteria (harmful for gums)	Technique used = Polymerase Chain Reaction (PCR) Measure unit = Colony-Forming Unit (CFU)	Collection on Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of the presence of parasites Entamoeba gingivalis subtype 1 (ST1) and subtype 2 (ST2) and Trichomonas tenax	Technique = Polymerase Chain Reaction (PCR) Unit = Colony-Forming Unit (CFU)	Collection on Day 1
Assessment of the periodontal status of patients with Autism Spectrum Disorder	Index used = the Dutch Periodontal Index 0 = minimum value, better outcome 4 = maximum value, worse outcome	Day 1
Assessment of the dental condition	Dental data will be collected using the Decay-Missing-Filled/Teeth (DMFT) score 0 = minimum value, best outcome 28 = maximum value, worst outcome	Day 1
Assessment of oral hygiene	Oral hygiene will be assessed using the Silness and Löe plaque index and the lifestyle questionnaire 0 = minimum value, best outcome 3 = maximum value, worst outcome	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	Data collection via a form fulfilled by the participant or the patient's legal guardian	Before samples collection and clinical examination

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France
• Investigators: Principal Investigator: Ludivine BERBE, CHRU Nancy

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2023
• Primary Completion (Estimated): August 1, 2023
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: June 7, 2023
• First Submitted That Met QC Criteria: June 15, 2023
• First Posted (Estimated): June 19, 2023

Study Record Updates

• Last Update Posted (Estimated): June 19, 2023
• Last Update Submitted That Met QC Criteria: June 15, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Autism Spectrum Disorder; Oral Health; Oral microbiota
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
• Other Study ID Numbers: 2023-A01024-41

Drug and device information, study documents

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