Evaluation of Some Inflammatory Markers in Autism Spectrum Disorders

• Sponsor: Assiut University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05803005
• Collaborator: (none)
• Enrollment: 100
• Anticipated Duration (Months): 13

Study Details

Study Description

Brief Summary

Evaluate some Inflammatory markers [IL-6, IL-8, TNF_alpha] in children with autism spectrum disorder

Condition or Disease	Intervention/Treatment	Phase
Autism Spectrum Disorder	Other: inflammatory marker in autism spectrum disorder

Detailed Description

several studies have suggested a correlation between ASD and abnormal immune activation (9) For instance, there is a high incidence of autistic subjects in families with other autoimmune disorders such as celiac disease and rheumatoid arthritis, suggesting a potential role for immune dysfunction in the pathophysiology of ASD High levels of IL-6 in the brain could determine alterations of synapse formation, dendritic spine development, and neuronal circuit balance [13], while in plasma they have been associated with increased stereotypical behaviors and with regressive forms of ASD

Study Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Case-Control
• Time Perspective: Retrospective
• Official Title: Evaluation of Some Inflammatory Markers in Autism Spectrum Disorders
• Anticipated Study Start Date: Sep 1, 2023
• Anticipated Primary Completion Date: Sep 1, 2024
• Anticipated Study Completion Date: Oct 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
children with autism spectrum disorder : 50 patients aged 3_18 years, equally sex distributed, who visit pediatric neurology outpatients clinic with autistic disorder at assiut university hospital will enrolled in this study and 50 controls . (According to DSM IV and ADT-R)	Other: inflammatory marker in autism spectrum disorder; Evaluate some Inflammatory markers [IL-6, IL-8, TNF_alpha] in children with autism spectrum disorder

Outcome Measures

Primary Outcome Measures

1. inflammatory marker in autism [baseline]

   Evaluate some Inflammatory markers [IL-6, IL-8, TNF_alpha] in children with autism spectrum disorder

Eligibility Criteria

Criteria

• Ages Eligible for Study: 3 Years to 18 Years
• Sexes Eligible for Study: All

Inclusion Criteria:

• 50 patients aged 3_18 years, equally sex distributed, who visit pediatric neurology outpatients clinic with autistic disorder at assiut university hospital will enrolled in this study and 50 controls . (According to DSM IV and ADT-R)

Exclusion Criteria:

• : Asperger syndrome, pervasive developmental disorder not otherwise specified (PDD-NOS), chronic seizures and recent infection and patients with congenital anomalies

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Assiut University

Investigators

• Study Director: gehan kamal, prof., assiut universtiy

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ghada Mohamed Ali, assiut, Assiut University
• ClinicalTrials.gov Identifier: NCT05803005
• Other Study ID Numbers: inflammatory markers in autism
• First Posted: Apr 7, 2023
• Last Update Posted: Apr 7, 2023
• Last Verified: Mar 1, 2023

• 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: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive

Study Results

No Results Posted as of Apr 7, 2023