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

Primary Purpose

Autism Spectrum Disorder

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
collection of saliva, gum fluid and/or dental plaque samples
Sponsored by
Central Hospital, Nancy, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Autism Spectrum Disorder focused on measuring Autism Spectrum Disorder, Oral microbiota, Oral Health

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Adults with Autism Spectrum Disorder

    Arm Description

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

    Outcomes

    Primary Outcome Measures

    Presence of periodontopathogenic bacteria (harmful for gums)
    Technique used = Polymerase Chain Reaction (PCR) Measure unit = Colony-Forming Unit (CFU)

    Secondary Outcome Measures

    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)
    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
    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
    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
    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

    Full Information

    First Posted
    June 7, 2023
    Last Updated
    June 15, 2023
    Sponsor
    Central Hospital, Nancy, France
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05910424
    Brief Title
    Oral Microbiota and Oral Status of Adult Patients With Autism Spectrum Disorders (MICAA: MICrobiota Autism Adults)
    Acronym
    MICAA
    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

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 2023 (Anticipated)
    Primary Completion Date
    August 2023 (Anticipated)
    Study Completion Date
    July 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Central Hospital, Nancy, France

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Autism Spectrum Disorder
    Keywords
    Autism Spectrum Disorder, Oral microbiota, Oral Health

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Pilot study concerning adults with autism spectrum disorder
    Masking
    None (Open Label)
    Masking Description
    No Treatment
    Allocation
    N/A
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Adults with Autism Spectrum Disorder
    Arm Type
    Experimental
    Arm Description
    Adults with autism spectrum disorder Aged between 18 and 60 years old Dental cares and follow-up in Nancy hospital
    Intervention Type
    Other
    Intervention Name(s)
    collection of saliva, gum fluid and/or dental plaque samples
    Intervention Description
    Non-invasive sampling of dental plaque, crevicular fluid and/or saliva, using an examination probe, paper tips and saliva swabs
    Primary Outcome Measure Information:
    Title
    Presence of periodontopathogenic bacteria (harmful for gums)
    Description
    Technique used = Polymerase Chain Reaction (PCR) Measure unit = Colony-Forming Unit (CFU)
    Time Frame
    Collection on Day 1
    Secondary Outcome Measure Information:
    Title
    Assessment of the presence of parasites Entamoeba gingivalis subtype 1 (ST1) and subtype 2 (ST2) and Trichomonas tenax
    Description
    Technique = Polymerase Chain Reaction (PCR) Unit = Colony-Forming Unit (CFU)
    Time Frame
    Collection on Day 1
    Title
    Assessment of the periodontal status of patients with Autism Spectrum Disorder
    Description
    Index used = the Dutch Periodontal Index 0 = minimum value, better outcome 4 = maximum value, worse outcome
    Time Frame
    Day 1
    Title
    Assessment of the dental condition
    Description
    Dental data will be collected using the Decay-Missing-Filled/Teeth (DMFT) score 0 = minimum value, best outcome 28 = maximum value, worst outcome
    Time Frame
    Day 1
    Title
    Assessment of oral hygiene
    Description
    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
    Time Frame
    Day 1
    Title
    Collection of data about lifestyle habits (oral and dental hygiene, diet, activity, etc.) and drug treatments that may influence the clinical parameters observed
    Description
    Data collection via a form fulfilled by the participant or the patient's legal guardian
    Time Frame
    Before samples collection and clinical examination

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    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)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ludivine BERBE
    Phone
    0033383154256
    Email
    ludivine.berbe@univ-lorraine.fr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ludivine BERBE
    Organizational Affiliation
    CHRU Nancy
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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