The Association Between Herpes Simplex Viruses and Autism

Sponsor
Assiut University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03180112
Collaborator
(none)
80
18

Study Details

Study Description

Brief 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 problems. Autism spectrum disorders manifest during childhood and at least thirty percent present with sudden clinical regression of development around three years of age.

Condition or Disease Intervention/Treatment Phase
  • Genetic: enzyme linked immunosorbent assay and polymerase chain reaction

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

Study Type:
Observational
Anticipated Enrollment :
80 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
The Association Between Herpes Simplex Viruses (Type One and Two) and Autism Spectrum Disorders
Anticipated Study Start Date :
Aug 1, 2017
Anticipated Primary Completion Date :
Aug 1, 2018
Anticipated Study Completion Date :
Feb 1, 2019

Arms and Interventions

Arm Intervention/Treatment
case group

Children suffering from Autism Spectrum disorders of variable grades attending to assiut University Children Hospital aged between six months and five years.

Genetic: enzyme linked immunosorbent assay and polymerase chain reaction
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.

control group

Healthy children of matching age and sex.

Genetic: enzyme linked immunosorbent assay and polymerase chain reaction
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.

Outcome Measures

Primary Outcome Measures

  1. relationship between herpes simplex viruses infections and development of autism. [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Months to 5 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Children suffering from Autism spectrum disorders.

  2. Age between six months and five years

Exclusion Criteria:
  1. Genetic disorders.

  2. History of metabolic or neurodegenerative disease.

  3. Gross motor delay.

  4. Audiologic problems.

  5. Mental retardation.

  6. Other psychiatric problems.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Khalaf A Sayed, principle investigator, Assiut University
ClinicalTrials.gov Identifier:
NCT03180112
Other Study ID Numbers:
  • HA
First Posted:
Jun 8, 2017
Last Update Posted:
Jun 8, 2017
Last Verified:
Jun 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 8, 2017