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TLR Polymorphism, ASO and Beta-hemolytic Group A Streptococcus Infections in ADHD: an Observational Study (TLR;)

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ClinicalTrials.gov Identifier: NCT04038073
Recruitment Status : Recruiting
First Posted : July 30, 2019
Last Update Posted : March 25, 2020
Sponsor:
Information provided by (Responsible Party):
Francesco Oliva, University of Turin, Italy

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.

Condition or disease Intervention/treatment
Attention Deficit-Hyperactivity Disorder Diagnostic Test: Antistreptolysin O Test Diagnostic Test: Anti-Deoxyribonuclease B Diagnostic Test: TLR, MyD88, IRAK-4 polymorphism Diagnostic Test: Anti-Basal Ganglia Antibody

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Toll-Like Receptor Polymorphism, Antinuclear Antibodies and Beta-hemolytic Group A Streptococcus Infections in Attention-Deficit/Hyperactivity Disorder: an Observational Study
Actual Study Start Date : June 3, 2019
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : December 1, 2020


Group/Cohort Intervention/treatment
ADHD
Attention Deficit/Hyperactivity Disorder
Diagnostic Test: Antistreptolysin O Test
Test to evaluate of any histories of streptococcal infections
Other Name: ASO

Diagnostic Test: Anti-Deoxyribonuclease B
Test to evaluate of any histories of streptococcal infections
Other Name: Anti-DNase B

Diagnostic Test: TLR, MyD88, IRAK-4 polymorphism
Test to evaluate of the frequency and types of genetic alterations of innate immunity

Diagnostic Test: Anti-Basal Ganglia Antibody
Test to evaluate the autoimmune component
Other Name: ABGA




Primary Outcome Measures :
  1. Measurement of Antistreptolysin O and Anti-Deoxyribonuclease B [ Time Frame: up to 1 year till the end of the study ]
    diagnostic blood sample test to measure streptococcal infections

  2. Measurement of TLR, MyD88, IRAK-4 polymorphism [ Time Frame: up to 1 year till the end of the study ]
    diagnostic blood sample test to measure genetic alterations of innate immunity

  3. Measurement of Anti-Basal Ganglia Antibody [ Time Frame: up to 1 year till the end of the study ]
    diagnostic blood sample test to assess the autoimmune component



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Participants with ADHD disgnosis (according to DSM-5 criteria) will be recruited for a single blood sample.
Criteria

Inclusion Criteria:

  • diagnosis of ADHD according to DSM-5 criteria

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04038073


Contacts
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Contact: Francesco Oliva 3335613155 francesco.oliva@unito.it

Locations
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Italy
AOU San Luigi Gonzaga di Orbassano Recruiting
Orbassano, Torino, Italy, 10043
Contact: Francesco Oliva    3335613155    francesco.oliva@unito.it   
Sponsors and Collaborators
University of Turin, Italy
Investigators
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Principal Investigator: Francesco Oliva University of Turin, Italy
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Responsible Party: Francesco Oliva, Research Assistant Professor, University of Turin, Italy
ClinicalTrials.gov Identifier: NCT04038073    
Other Study ID Numbers: ADHD_TLR
First Posted: July 30, 2019    Key Record Dates
Last Update Posted: March 25, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Streptococcal Infections
Hyperkinesis
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Gram-Positive Bacterial Infections
Bacterial Infections
Antibodies
Antistreptolysin
Immunologic Factors
Physiological Effects of Drugs