Autism Spectrum DisorderNCT05803005
Evaluation of Some Inflammatory Markers in Autism Spectrum Disorders
An observational study of Autism Spectrum Disorder, run by Assiut University.
Trial summary
Evaluate some Inflammatory markers [IL-6, IL-8, TNF_alpha] in children with autism spectrum disorder Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- inflammatory marker in autism spectrum disorder
- Type of treatment
- Injection or infusion
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2023to 1 Oct 2024
- 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 3 to 18 years
- All sexes
- Child, Adult
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)
Who may be able to join
- 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)
Who cannot join
- : Asperger syndrome, pervasive developmental disorder not otherwise specified (PDD-NOS), chronic seizures and recent infection and patients with congenital anomalies
Trial locations and contacts
No sites are listed yet.
About this study
Evaluate some Inflammatory markers [IL-6, IL-8, TNF_alpha] in children with autism spectrum disorder
Read the 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
- Conditions
- Autism Spectrum Disorder
- Being tested
- inflammatory marker in autism spectrum disorder
- 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.
inflammatory marker in autism spectrum disorderOther
Evaluate some Inflammatory markers [IL-6, IL-8, TNF_alpha] in children with autism spectrum disorder
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: inflammatory marker in autism spectrum disorder |
What is being measured
The primary outcome is the main question the study is designed to answer.
inflammatory marker in autism
Evaluate some Inflammatory markers [IL-6, IL-8, TNF_alpha] in children with autism spectrum disorder
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2023
- Study start1 Sep 2023 (estimated)
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ghada Mohamed Ali, Assiut University
- Investigators
- gehan kamal, prof., Study director, assiut universtiy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05803005
- Sponsor's protocol ID
- inflammatory markers in autism
- Status last verified
- Mar 2023
- First submitted
- 26 Mar 2023
- Last updated
- 7 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Some Inflammatory Markers in Autism Spectrum Disorders
- ClinicalTrials.gov ID
- NCT05803005
- Acronym / sponsor ID
- inflammatory markers in autism
- Conditions
- Autism Spectrum Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 7 Apr 2023 (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.
Evaluate some Inflammatory markers [IL-6, IL-8, TNF_alpha] in children with 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
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| children with autism spectrum disorder | – | Other: inflammatory marker in 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) |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Age groups
- Child, Adult
- 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)
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (1 listed)
- : Asperger syndrome, pervasive developmental disorder not otherwise specified (PDD-NOS), chronic seizures and recent infection and patients with congenital anomalies
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 |
|---|---|---|
| inflammatory marker in autism spectrum disorderEvaluate some Inflammatory markers [IL-6, IL-8, TNF_alpha] in children with autism spectrum disorder | Other | children with autism spectrum disorder |
Primary outcome
inflammatory marker in autism
Time frame: baseline
Evaluate some Inflammatory markers [IL-6, IL-8, TNF_alpha] in children with autism spectrum disorder
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2023.
- Individual participant dataSharing planned: No
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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.
gehan kamal, prof. study director
assiut universtiy
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 1 inclusion and 1 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 7 Apr 2023. 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 ghada ali, graduated (01060012214, doddamohamed96@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
inflammatory marker in autism (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Apr 2023.