Gut-oral Axis Microbiome in Autism Spectrum Disorders
The Role of Gut-oral Axis Microbiome in Autism Spectrum Disorders
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Contacts and Locations
Study Contact
Study Contact
- Name: Manola Comar, BSc
- Phone Number: +39.040.3785.527
- Email: manola.comar@burlo.trieste.it
Study Contact Backup
- Name: Manola Comar, BSc
- Phone Number: +390403785527
- Email: manola.comar@burlo.trieste.it
Study Locations
-
-
-
Trieste, Italy, 34137
- Recruiting
- Institute for Maternal and Child Health - IRCCS "Burlo Garofolo"
-
Contact:
- Manola Comar, BSc
- Phone Number: +39.040.3785.527
- Email: manola.comar@burlo.trieste.it
-
Contact:
- Manola Comar, BSc
- Phone Number: +39040.3785527
- Email: manola.comar@burlo.trieste.it
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Pediatric subjects:
- children coming to the Division of Child Neurology and Psychiatry for the first clinical evaluation (1 year to 5 years old)
- children with confirmed ASD diagnosis (6 years to 17 years old) coming to the Odonto-Stomatology Department for the periodical dental hygiene session.
- children control group with matched demographic characteristics accessing our Institute for different purposes
Description
INCLUSION CRITERIA
Case group
- Caucasian
- Diagnosed with ASD or with a newly formulated diagnosis of ASD
- Aged between 1 and 17 years
Control group
- Caucasian
- Healthy at the time of sampling
- No ASD or other neurological disorders
- Aged between 1 and 17 years
EXCLUSION CRITERIA
- Antibiotic use in the month before sample collection
- Probiotic use in the month before sample collection
- Other neurological diseases
- Chronic inflammatory diseases
- The use of constipation drugs during the three days before sample collection
Study Plan
How is the study designed?
Design Details
Number of groups / cohorts
Cohorts and Interventions
Group / CohortGroup / Cohort |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Children with autism disorders 1-5 years
Children coming to the Division of Child Neurology and Psychiatry for the first clinical evaluation (1 year to 5 years old)
|
The oral and fecal samples are collected during the periodical dental hygiene session at the odonto-stomatology unit and during day hospital for younger children admitted for the first clinical evaluation at Division of Child Neurology and Psychiatry.
Procedures will follow standardized protocols.
|
|
Children with autism disorders 6-17 years
Children with confirmed ASD diagnosis (6 years to 17 years old) coming to the Odonto-Stomatology Department for the periodical dental hygiene session
|
The oral and fecal samples are collected during the periodical dental hygiene session at the odonto-stomatology unit and during day hospital for younger children admitted for the first clinical evaluation at Division of Child Neurology and Psychiatry.
Procedures will follow standardized protocols.
|
|
Children control group
Children with matched demographic characteristics accessing our Institute for different purposes
|
The oral and fecal samples are collected during the periodical dental hygiene session at the odonto-stomatology unit and during day hospital for younger children admitted for the first clinical evaluation at Division of Child Neurology and Psychiatry.
Procedures will follow standardized protocols.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
To compare oral and GI microbiota
Time Frame: At baseline
|
Oral and GI bacterial species will be evaluated in oral and fecal samples collected and compared through bioinformatic and statistical analysis among case and control groups to isolate the discriminant ones.
The technical activity is focused on samples DNA extraction and sequencing and on a culturomic approach.
|
At baseline
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
To evaluate the association between the key bacteria species found in ASD microbiota and soluble concentration of salivary cytokines
Time Frame: At baseline
|
Oral and GI bacterial species will be evaluated in oral and fecal samples.
The soluble concentrations (picograms per millilitre) of a panel of 27 cytokines and chemokines will be simultaneously assessed in saliva samples.
|
At baseline
|
|
To evaluate the association between the key bacteria species found in ASD microbiota and soluble concentration of salivary chemokines
Time Frame: At baseline
|
Oral and GI bacterial species will be evaluated in oral and fecal samples.
The soluble concentrations (picograms per millilitre) of a panel of 27 cytokines and chemokines will be simultaneously assessed in saliva samples.
|
At baseline
|
|
To evaluate the association between the microbiota structure and the severity of the ASD symptoms
Time Frame: At baseline
|
Oral and GI bacterial species will be evaluated in oral and fecal samples.
Clinical data will be collected from medical records.
|
At baseline
|
|
To evaluate the association between the microbiota structure and eating habits of ASD children
Time Frame: At baseline
|
A food diary will be distributed at enrollment to evaluate eating habits of ASD children
|
At baseline
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Study Director: Manola Comar, BSc, Institute for Maternal and Child Health IRCCS Burlo Garofolo
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- RC 20/21
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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