Evaluation of Some Inflammatory Markers in Autism Spectrum Disorders

March 26, 2023 updated by: Ghada Mohamed Ali, Assiut University
Evaluate some Inflammatory markers [IL-6, IL-8, TNF_alpha] in children with autism spectrum disorder

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

: 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)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
inflammatory marker in autism
Time Frame: baseline
Evaluate some Inflammatory markers [IL-6, IL-8, TNF_alpha] in children with autism spectrum disorder
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2023

Primary Completion (Anticipated)

September 1, 2024

Study Completion (Anticipated)

October 1, 2024

Study Registration Dates

First Submitted

March 26, 2023

First Submitted That Met QC Criteria

March 26, 2023

First Posted (Actual)

April 7, 2023

Study Record Updates

Last Update Posted (Actual)

April 7, 2023

Last Update Submitted That Met QC Criteria

March 26, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • inflammatory markers in autism

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Autism Spectrum Disorder

Clinical Trials on inflammatory marker in autism spectrum disorder

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Serbia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe