Autism Spectrum DisorderMICAANCT05910424
Oral Microbiota and Oral Status of Adult Patients With Autism Spectrum Disorders (MICAA: MICrobiota Autism Adults)
A study testing collection of saliva, gum fluid and/or dental plaque samples in people with Autism Spectrum Disorder, run by Central Hospital, Nancy, France at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- collection of saliva, gum fluid and/or dental plaque samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteFrance
- Study dates
- 22 Nov 2023to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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:
Show all 11Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Autism Spectrum Disorder
- Being tested
- collection of saliva, gum fluid and/or dental plaque samples
- Keywords
- Autism Spectrum Disorder, Oral microbiota, Oral Health
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
collection of saliva, gum fluid and/or dental plaque samplesOther
Non-invasive sampling of dental plaque, crevicular fluid and/or saliva, using an examination probe, paper tips and saliva swabs
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: collection of saliva, gum fluid and/or dental plaque samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of periodontopathogenic bacteria (harmful for gums)
Technique used = Polymerase Chain Reaction (PCR) Measure unit = Colony-Forming Unit (CFU)
Measured: 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
Technique = Polymerase Chain Reaction (PCR) Unit = Colony-Forming Unit (CFU)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Before samples collection and clinical examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start22 Nov 2023
- Primary completion9 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pilot study concerning adults with autism spectrum disorder
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, BERBE Ludivine, Central Hospital, Nancy, France
- Investigators
- Ludivine BERBE, Principal investigator, CHRU Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05910424
- Sponsor's protocol ID
- 2023-A01024-41
- Acronym
- MICAA
- Status last verified
- Aug 2024
- First submitted
- 7 Jun 2023
- Last updated
- 26 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterisation of the Oral Microbiota and Oral Status of a Population of Adult Patients With Autism Spectrum Disorders: a Pilot Study
- ClinicalTrials.gov ID
- NCT05910424
- Acronym / sponsor ID
- MICAA / 2023-A01024-41
- Conditions
- Autism Spectrum Disorder
- Keywords
- Autism Spectrum Disorder, Oral microbiota, Oral Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 22 Nov 2023 (actual)
- Primary completion
- 9 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 18 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pilot study concerning adults with autism spectrum disorder
| Arm | Type | Receives |
|---|---|---|
| Adults with Autism Spectrum Disorder | Experimental | Other: collection of saliva, gum fluid and/or dental plaque samples* Adults with autism spectrum disorder * Aged between 18 and 60 years old * Dental cares and follow-up in Nancy hospital |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| collection of saliva, gum fluid and/or dental plaque samplesNon-invasive sampling of dental plaque, crevicular fluid and/or saliva, using an examination probe, paper tips and saliva swabs | Other | Adults with Autism Spectrum Disorder |
Primary outcome
Presence of periodontopathogenic bacteria (harmful for gums)
Time frame: Collection on Day 1
Technique used = Polymerase Chain Reaction (PCR) Measure unit = Colony-Forming Unit (CFU)
5 secondary outcomes
Assessment of the presence of parasites Entamoeba gingivalis subtype 1 (ST1) and subtype 2 (ST2) and Trichomonas tenax
Time frame: Collection on Day 1
Assessment of the periodontal status of patients with Autism Spectrum Disorder
Time frame: Day 1
Assessment of the dental condition
Time frame: Day 1
Assessment of oral hygiene
Time frame: 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
Time frame: Before samples collection and clinical examination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ludivine BERBE principal investigator
CHRU Nancy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing collection of saliva, gum fluid and/or dental plaque samples in people with Autism Spectrum Disorder, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of periodontopathogenic bacteria (harmful for gums) (time frame: Collection on Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2024.