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TLR;
Toll-Like Receptor Polymorphism, Antinuclear Antibodies and Beta-hemolytic Group A Streptococcus Infections in Attention-Deficit/Hyperactivity Disorder: an Observational Study
Sponsor study identifier
observational
100
1 country
1
Study Start
June 3, 2019
Actual (reported)Primary Completion
June 30, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 1, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 1, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 3, 2019
Actual (reported)July 24, 2019
Actual (reported)July 30, 2019
Actual (reported)June 30, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 1, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
Attention Deficit/Hyperactivity Disorder
Test to evaluate of any histories of streptococcal infections
Test to evaluate of any histories of streptococcal infections
Participants with ADHD disgnosis (according to DSM-5 criteria) will be recruited for a single blood sample.
Contact the study team to confirm eligibility.
AOU San Luigi Gonzaga di Orbassano
Orbassano, Torino, 10043, Italy
Francesco Oliva
University of Turin, Italy
First Submitted
July 24, 2019
First Posted
July 30, 2019
Study Start
June 3, 2019
Actual (reported)Primary Completion
June 30, 2020
Estimated (date passed)Test to evaluate of the frequency and types of genetic alterations of innate immunity
Test to evaluate the autoimmune component
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 1, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
March 25, 2020
Record last verified: 2020-03
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Source: ClinicalTrials.gov.
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