TLR Polymorphism, ASO and Beta-hemolytic Group A Streptococcus Infections in ADHD: an Observational Study
TLR;
Toll-Like Receptor Polymorphism, Antinuclear Antibodies and Beta-hemolytic Group A Streptococcus Infections in Attention-Deficit/Hyperactivity Disorder: an Observational Study
1 other identifier
observational
100
1 country
1
Brief Summary
The aim of this observational cross-sectional study is to evaluate the streptococcal infection (clinical history, ASLO title and anti-DNAse title B) and autoimmunity (ABGA antibodies) in a sample of 100 adult patients diagnosed with ADHD (ie in patients in whom the disorder is permanent). Another objective will be to evaluate the frequency and types of genetic alterations of innate immunity (TLR polymorphisms, MyD88, IRAK-4) that can determine an infantile susceptibility to gram positive infections (ie S. pyogenes, S. pneumoniae, S. aureus) and the possible relationship between these elements, also in relation to comorbidity with other ABGA-related pathologies, to identify a possible pathogenetic immune mechanism of ADHD. Prevalence data will be obtained on an outpatient ADHD population for previous (history) and recent streptococcal infection (ASLO and Anti-DNAsiB), for the detection of ABGA and for the co-presence of other ABGA-related pathologies. By comparing the subgroups obtained by dividing the results on the basis of the positive infectious history, anti-streptococcus, autoantibody and comorbidity titers, it will be possible to assess whether the elevation of the ABGA titer is only linked to the previous/current infection ("infectious" group) or if there is a subpopulation of ADHD patients presenting pathological elevation of ABGA titers in the absence of infectious pictures ("immune" group). Furthermore, it is expected that the comparison of the descriptive polymorphisms TLR, MyD88 and IRAK-4 between the "infectious" and "immune" group may show a predisposition in subjects of the "immune" group.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 3, 2019
CompletedFirst Submitted
Initial submission to the registry
July 24, 2019
CompletedFirst Posted
Study publicly available on registry
July 30, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedMarch 25, 2020
March 1, 2020
1.1 years
July 24, 2019
March 23, 2020
Conditions
Outcome Measures
Primary Outcomes (3)
Measurement of Antistreptolysin O and Anti-Deoxyribonuclease B
diagnostic blood sample test to measure streptococcal infections
up to 1 year till the end of the study
Measurement of TLR, MyD88, IRAK-4 polymorphism
diagnostic blood sample test to measure genetic alterations of innate immunity
up to 1 year till the end of the study
Measurement of Anti-Basal Ganglia Antibody
diagnostic blood sample test to assess the autoimmune component
up to 1 year till the end of the study
Study Arms (1)
ADHD
Attention Deficit/Hyperactivity Disorder
Interventions
Test to evaluate of any histories of streptococcal infections
Test to evaluate of any histories of streptococcal infections
Test to evaluate of the frequency and types of genetic alterations of innate immunity
Test to evaluate the autoimmune component
Eligibility Criteria
Participants with ADHD disgnosis (according to DSM-5 criteria) will be recruited for a single blood sample.
You may qualify if:
- diagnosis of ADHD according to DSM-5 criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
AOU San Luigi Gonzaga di Orbassano
Orbassano, Torino, 10043, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Francesco Oliva
University of Turin, Italy
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Assistant Professor
Study Record Dates
First Submitted
July 24, 2019
First Posted
July 30, 2019
Study Start
June 3, 2019
Primary Completion
June 30, 2020
Study Completion
December 1, 2020
Last Updated
March 25, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will not share