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

Autism Spectrum Disorder Clinical Trial

— MICAA  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05910424
• Other study ID #: 2023-A01024-41
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2023
• Est. completion date: July 2025

Study information

• Verified date: June 2023
• Source: Central Hospital, Nancy, France
• Contact: Ludivine BERBE
• Phone: 0033383154256
• Email: ludivine.berbe[@]univ-lorraine.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: July 2025
• Est. primary completion date: August 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of periodontopathogenic bacteria (harmful for gums)	Technique used = Polymerase Chain Reaction (PCR) Measure unit = Colony-Forming Unit (CFU)	Collection on Day 1
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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