Autism Spectrum DisorderNCT03180112
The Association Between Herpes Simplex Viruses and Autism
An observational study of Autism Spectrum Disorder, run by Assiut University.
Trial summary
Autism spectrum disorders are pervasive developmental disorders that include autistic disorder, Asperger's disorder, and pervasive developmental disorder-not otherwise specified.They are characterized by stereotypic behaviors, variable deficits in language and social skills and a wide range of other behavioral… Read more about this study
- Who is it for?
- Ages 6 months to 5 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- enzyme linked immunosorbent assay and polymerase chain reaction
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2017to 1 Feb 2019
- Phase
- Observational
- 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 6 months to 5 years
- All sexes
- No healthy volunteers
- Child
Study population: Children suffering from Autism Spectrum disorders of variable grades attending to Assuit University Children Hospital and the same number of healthy children of matching age and sex as a control. Age between six months and five years
Who may be able to join
- Children suffering from Autism spectrum disorders.
- Age between six months and five years
Who cannot join
- Genetic disorders.
- History of metabolic or neurodegenerative disease.
- Gross motor delay.
- Audiologic problems.
- Mental retardation.
- Other psychiatric problems.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Association Between Herpes Simplex Viruses (Type One and Two) and Autism Spectrum Disorders
Autism spectrum disorders are pervasive developmental disorders that include autistic disorder, Asperger's disorder, and pervasive developmental disorder-not otherwise specified.They are characterized by stereotypic behaviors, variable deficits in language and social skills and a wide range of other behavioral problems. Autism spectrum disorders manifest during childhood and at least thirty percent present with sudden clinical regression of development around three years of age.
Read the detailed description
Over the last twenty years, there has been an impressive rise in Autism spectrum disorders with current prevalence estimates being about one over one hundred children.
Herpes simplex virus encephalitis is the leading cause of sporadic, nonepidemic encephalitis in children and adults in the United States. It is an acute necrotizing infection generally involving the frontal and/or temporal cortex and the limbic system and, beyond the neonatal period, is almost always caused by Herpes simplex virus type on.
The etiology of autism is unknown; data suggest that autism results from multiple etiologies with both genetic and environmental contributions. One proposed etiology for autism is viral infection very early in development. The mechanism, by which viral infection may lead to autism, be it through direct infection of the central nervous system, through infection elsewhere in the body acting as a trigger for disease in the central nervous system, through alteration of the immune response of the mother or offspring, or through a combination of these, is not yet known.
Many encephalitic patients had temporal lobe involvement. Autism results from neuropathology relating to the temporal lobes. They speculate the differences in the extent and neuropathologies of the temporal lobes contribute to the heterogeneity of autism. Also, herpes viruses can induce a variety of proinflammatory cytokines during infections, along with elevated interferon in the brain during Herpes simplex virus encephalitis.
- Conditions
- Autism Spectrum Disorder
- Being tested
- enzyme linked immunosorbent assay and polymerase chain reaction
- 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.
enzyme linked immunosorbent assay and polymerase chain reactionGenetic
Blood samples will be collected and analyzed for herpes simplex viruses (type one and two) antibody by sensitive enzyme-linked immunosorbent assay and quantitative polymerase chain reaction.
| Study group | Role | What they receive |
|---|---|---|
| case group | Children suffering from Autism Spectrum disorders of variable grades attending to assiut University Children Hospital aged between six months and five years. Receives: Genetic: enzyme linked immunosorbent assay and polymerase chain reaction | |
| control group | Healthy children of matching age and sex. Receives: Genetic: enzyme linked immunosorbent assay and polymerase chain reaction |
What is being measured
The primary outcome is the main question the study is designed to answer.
relationship between herpes simplex viruses infections and development of autism.
Detection of herpes simplex viruses antibody titre by sensitive enzyme linked immunosorbent assay and detection of herpes simplex viruses titre by quantitative polymerase chain reaction
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2017
- Study start1 Aug 2017 (estimated)
- Primary completion1 Aug 2018 (estimated)
- Study completion1 Feb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khalaf A Sayed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03180112
- Sponsor's protocol ID
- HA
- Status last verified
- Jun 2017
- First submitted
- 1 Jun 2017
- Last updated
- 8 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Johnson CP, Myers SM; American Academy of Pediatrics Council on Children With Disabilities. Identification and evaluation of children with autism spectrum disorders. Pediatrics. 2007 Nov;120(5):1183-215. doi: 10.1542/peds.2007-2361. Epub 2007 Oct 29.
PubMed 17967920Zappella M. Autistic regression with and without EEG abnormalities followed by favourable outcome. Brain Dev. 2010 Oct;32(9):739-45. doi: 10.1016/j.braindev.2010.05.004. Epub 2010 Aug 12.
PubMed 20708360Fombonne E. Epidemiology of pervasive developmental disorders. Pediatr Res. 2009 Jun;65(6):591-8. doi: 10.1203/PDR.0b013e31819e7203.
PubMed 19218885Libbey JE, Sweeten TL, McMahon WM, Fujinami RS. Autistic disorder and viral infections. J Neurovirol. 2005 Feb;11(1):1-10. doi: 10.1080/13550280590900553.
PubMed 15804954DeLong GR, Bean SC, Brown FR 3rd. Acquired reversible autistic syndrome in acute encephalopathic illness in children. Arch Neurol. 1981 Mar;38(3):191-4. doi: 10.1001/archneur.1981.00510030085013.
PubMed 6162440Gillberg C. Onset at age 14 of a typical autistic syndrome. A case report of a girl with herpes simplex encephalitis. J Autism Dev Disord. 1986 Sep;16(3):369-75. doi: 10.1007/BF01531665. No abstract available.
PubMed 3558293Ghaziuddin M, Tsai LY, Eilers L, Ghaziuddin N. Brief report: autism and herpes simplex encephalitis. J Autism Dev Disord. 1992 Mar;22(1):107-13. doi: 10.1007/BF01046406. No abstract available.
PubMed 1592760Hetzler BE, Griffin JL. Infantile autism and the temporal lobe of the brain. J Autism Dev Disord. 1981 Sep;11(3):317-30. doi: 10.1007/BF01531514.
PubMed 6189814Dalod M, Salazar-Mather TP, Malmgaard L, Lewis C, Asselin-Paturel C, Briere F, Trinchieri G, Biron CA. Interferon alpha/beta and interleukin 12 responses to viral infections: pathways regulating dendritic cell cytokine expression in vivo. J Exp Med. 2002 Feb 18;195(4):517-28. doi: 10.1084/jem.20011672.
PubMed 11854364Salazar-Mather TP, Hamilton TA, Biron CA. A chemokine-to-cytokine-to-chemokine cascade critical in antiviral defense. J Clin Invest. 2000 Apr;105(7):985-93. doi: 10.1172/JCI9232.
PubMed 10749577Legaspi RC, Gatmaitan B, Bailey EJ, Lerner AM. Interferon in biopsy and autopsy specimens of brain. Its presence in herpes simplex virus encephalitis. Arch Neurol. 1980 Feb;37(2):76-9. doi: 10.1001/archneur.1980.00500510034004.
PubMed 7356411
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between Herpes Simplex Viruses (Type One and Two) and Autism Spectrum Disorders
- ClinicalTrials.gov ID
- NCT03180112
- Acronym / sponsor ID
- HA
- Conditions
- Autism Spectrum Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Aug 2017 (estimated)
- Primary completion
- 1 Aug 2018 (estimated)
- Study completion
- 1 Feb 2019 (estimated)
- First posted
- 8 Jun 2017 (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.
Autism spectrum disorders are pervasive developmental disorders that include autistic disorder, Asperger's disorder, and pervasive developmental disorder-not otherwise specified.They are characterized by stereotypic behaviors, variable deficits in language and social skills and a wide range of other behavioral problems. Autism spectrum disorders manifest during childhood and at least thirty percent present with sudden clinical regression of development around three years of age.
Detailed description
Over the last twenty years, there has been an impressive rise in Autism spectrum disorders with current prevalence estimates being about one over one hundred children.
Herpes simplex virus encephalitis is the leading cause of sporadic, nonepidemic encephalitis in children and adults in the United States. It is an acute necrotizing infection generally involving the frontal and/or temporal cortex and the limbic system and, beyond the neonatal period, is almost always caused by Herpes simplex virus type on.
The etiology of autism is unknown; data suggest that autism results from multiple etiologies with both genetic and environmental contributions. One proposed etiology for autism is viral infection very early in development. The mechanism, by which viral infection may lead to autism, be it through direct infection of the central nervous system, through infection elsewhere in the body acting as a trigger for disease in the central nervous system, through alteration of the immune response of the mother or offspring, or through a combination of these, is not yet known.
Many encephalitic patients had temporal lobe involvement. Autism results from neuropathology relating to the temporal lobes. They speculate the differences in the extent and neuropathologies of the temporal lobes contribute to the heterogeneity of autism. Also, herpes viruses can induce a variety of proinflammatory cytokines during infections, along with elevated interferon in the brain during Herpes simplex virus encephalitis.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| case group | – | Genetic: enzyme linked immunosorbent assay and polymerase chain reactionChildren suffering from Autism Spectrum disorders of variable grades attending to assiut University Children Hospital aged between six months and five years. |
| control group | – | Genetic: enzyme linked immunosorbent assay and polymerase chain reactionHealthy children of matching age and sex. |
Who may qualify
- Ages
- 6 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children suffering from Autism Spectrum disorders of variable grades attending to Assuit University Children Hospital and the same number of healthy children of matching age and sex as a control. Age between six months and five years
Key inclusion criteria (2 listed)
- Children suffering from Autism spectrum disorders.
- Age between six months and five years
Key exclusion criteria (6 listed)
- Genetic disorders.
- History of metabolic or neurodegenerative disease.
- Gross motor delay.
- Audiologic problems.
- Mental retardation.
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 |
|---|---|---|
| enzyme linked immunosorbent assay and polymerase chain reactionBlood samples will be collected and analyzed for herpes simplex viruses (type one and two) antibody by sensitive enzyme-linked immunosorbent assay and quantitative polymerase chain reaction. | Genetic | case group, control group |
Primary outcome
relationship between herpes simplex viruses infections and development of autism.
Time frame: 12 month
Detection of herpes simplex viruses antibody titre by sensitive enzyme linked immunosorbent assay and detection of herpes simplex viruses titre by quantitative polymerase chain reaction
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2017.
- Background: PubMed 17967920Johnson CP, Myers SM; American Academy of Pediatrics Council on Children With Disabilities. Identification and evaluation of children with autism spectrum disorders. Pediatrics. 2007 Nov;120(5):1183-215. doi: 10.1542/peds.2007-2361. Epub 2007 Oct 29.
- Background: PubMed 20708360Zappella M. Autistic regression with and without EEG abnormalities followed by favourable outcome. Brain Dev. 2010 Oct;32(9):739-45. doi: 10.1016/j.braindev.2010.05.004. Epub 2010 Aug 12.
- Background: PubMed 19218885Fombonne E. Epidemiology of pervasive developmental disorders. Pediatr Res. 2009 Jun;65(6):591-8. doi: 10.1203/PDR.0b013e31819e7203.
- Background: PubMed 15804954Libbey JE, Sweeten TL, McMahon WM, Fujinami RS. Autistic disorder and viral infections. J Neurovirol. 2005 Feb;11(1):1-10. doi: 10.1080/13550280590900553.
- Background: PubMed 6162440DeLong GR, Bean SC, Brown FR 3rd. Acquired reversible autistic syndrome in acute encephalopathic illness in children. Arch Neurol. 1981 Mar;38(3):191-4. doi: 10.1001/archneur.1981.00510030085013.
- Background: PubMed 3558293Gillberg C. Onset at age 14 of a typical autistic syndrome. A case report of a girl with herpes simplex encephalitis. J Autism Dev Disord. 1986 Sep;16(3):369-75. doi: 10.1007/BF01531665. No abstract available.
- Background: PubMed 1592760Ghaziuddin M, Tsai LY, Eilers L, Ghaziuddin N. Brief report: autism and herpes simplex encephalitis. J Autism Dev Disord. 1992 Mar;22(1):107-13. doi: 10.1007/BF01046406. No abstract available.
- Background: PubMed 6189814Hetzler BE, Griffin JL. Infantile autism and the temporal lobe of the brain. J Autism Dev Disord. 1981 Sep;11(3):317-30. doi: 10.1007/BF01531514.
- Background: PubMed 11854364Dalod M, Salazar-Mather TP, Malmgaard L, Lewis C, Asselin-Paturel C, Briere F, Trinchieri G, Biron CA. Interferon alpha/beta and interleukin 12 responses to viral infections: pathways regulating dendritic cell cytokine expression in vivo. J Exp Med. 2002 Feb 18;195(4):517-28. doi: 10.1084/jem.20011672.
- Background: PubMed 10749577Salazar-Mather TP, Hamilton TA, Biron CA. A chemokine-to-cytokine-to-chemokine cascade critical in antiviral defense. J Clin Invest. 2000 Apr;105(7):985-93. doi: 10.1172/JCI9232.
- Background: PubMed 7356411Legaspi RC, Gatmaitan B, Bailey EJ, Lerner AM. Interferon in biopsy and autopsy specimens of brain. Its presence in herpes simplex virus encephalitis. Arch Neurol. 1980 Feb;37(2):76-9. doi: 10.1001/archneur.1980.00500510034004.
- Individual participant dataSharing planned: No
Related trials for Autism Spectrum Disorder
Not yet recruiting
Single Session Support for Parents of Children With Neurodevelopmental Disabilities Struggling With Anxious Avoidance
Neurodevelopmental Disorders, Autism Spectrum Disorder (ASD)
Not yet recruiting
Evaluation of a Novel Quantum-Inspired Intervention (QII) for Children With Autism Spectrum Disorder: A Global Confirmatory Study
Autism Spectrum Disorder, Autism Spectrum Disorder (ASD
Recruiting
Strategies for Toddler ASD With Remote-therapy (STAR) Model for ASD
Autism Spectrum Disorder, Therapy
Recruiting
Smith Magenis Syndrome and Autism Spectrum Disorders
Smith-Magenis Syndrome, Autism Spectrum Disorder
Active, not recruitingPhase 1
Psilocybin for Treatment-Resistant Depression in Autism
Treatment Resistant Depression, Autism Spectrum Disorder
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism Spectrum Disorder, run by Assiut University.
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 2 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 8 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gamal Ali Abdelal, MD (+201111686162, Gamal.asker@med.au.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
relationship between herpes simplex viruses infections and development of autism. (time frame: 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03180112, which also lists 11 linked publications.
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 8 Jun 2017.