Toxoplasmosis in Neuropsychiatric DisordersNCT06980298
Toxoplasma Gondii Seroprevalence Among Children With Some Neuropsychiatric Disorders
An observational study of Toxoplasmosis in Neuropsychiatric Disorders, run by Sohag University at 1 site in Egypt.
Trial summary
Toxoplasma gondii is recognized as being involved in the etiology of various psychotic disorders including epilepsy and ADHD (Markovitz et al.,2015). There are many explanations for such associations between toxoplasmosis and neurological disorders which include many anatomical and neurotransmitter-related changes. Read more about this study
- Who is it for?
- Ages Up to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Toxoplasmosis in Neuropsychiatric Disorders
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- Jun 2025to Feb 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Up to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: 90 children will be collected from children ,45 of them have either epilepsy or ADHD and another matched 45 children for age and gender, served as control.
Inclusion criteria: Children with neuropsychiatric disorders (epilepsy,ADHD). Exclusion criteria: Children with history of neurosurgery, head injury or trauma, neoplastic or autoimmune diseases, or receiving immunosuppressant or systemic corticosteroid, and those with possible neurological infection.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Sohag University
Sohag
Alaa Abd Elhamid Elsayed, Demonstrator, +201100546404, alaa.abdelameed@med.sohag.edu.eg
Alaa Abd Elhamid Elsayed, Demonstrator
About this study
Official title: Toxoplasma Gondii Seroprevalence Among Children With Some Neuropsychiatric Disorders in Sohag Governorate, Egypt
Toxoplasma gondii is recognized as being involved in the etiology of various psychotic disorders including epilepsy and ADHD (Markovitz et al.,2015).
There are many explanations for such associations between toxoplasmosis and neurological disorders which include many anatomical and neurotransmitter-related changes. Toxoplasmosis may cause alterations in neurotransmitter levels like serotonin, noradrenaline, glutamate, nitric oxide and gamma aminobutyric acid, increase in the levels of proinflammatory cytokines and modulate the dopaminergic signaling (Babaie et al., 2017). The behavioral changes produced by the cyst formation in the brain tissue may also related to the localization of the cyst within specific parts of the brain and this is assumed to be one of the main causes of epilepsy in toxoplasmosis. Moreover, tachyzoites may invade the brain tissues and excite brain cells especially neurons, microglia and astrocytes. Additionally, the presence of Toxoplasma in brain evokes inflammatory response and stimulate immune system to produce antibodies with increase in proinflammatory cytokines. Interestingly, some studies described that many host genes and proteins could be affected by Toxoplasma, signifying its involvement in many genetic disorders including neuropsychiatric diseases.The current study aimed to assess the seroprevalence of anti-Toxoplasma IgM and IgG antibodies among children with some neuropsychiatric disorders (Epilepsy and ADHD) in Sohag governorate, Egypt.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Case group | 45 blood samples will be collected from children have either epilepsy or ADHD. Approximately 3 ml venous blood will be collected from each child by venipuncture, under sterile conditions. | |
| Control group | 45 blood samples will be collected from matched children for age and gender, served as control. Approximately 3 ml venous blood will be collected from each child by venipuncture, under sterile conditions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison between incidence of Toxoplasma gondii in children with neuropsychiatric disorders and children without neuropsychiatric disorders
Measured: 6 months
Secondary outcomes (1)
Prevalence of Toxoplasma gondii in children with neuropsychiatric disorders
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2025
- Study startJun 2025 (estimated)
- Primary completionOct 2025 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Toxoplasmosis in Neuropsychiatric DisordersStudies of the same condition, open and under way.
- More trials run by Sohag 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
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Abdelhameed Elsayed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06980298
- Sponsor's protocol ID
- Soh-Med--25-4-04MS
- Status last verified
- May 2025
- First submitted
- 12 May 2025
- Last updated
- 20 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Toxoplasma Gondii Seroprevalence Among Children With Some Neuropsychiatric Disorders in Sohag Governorate, Egypt
- ClinicalTrials.gov ID
- NCT06980298
- Acronym / sponsor ID
- Soh-Med--25-4-04MS
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Jun 2025 (estimated)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 20 May 2025 (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.
Toxoplasma gondii is recognized as being involved in the etiology of various psychotic disorders including epilepsy and ADHD (Markovitz et al.,2015).
There are many explanations for such associations between toxoplasmosis and neurological disorders which include many anatomical and neurotransmitter-related changes. Toxoplasmosis may cause alterations in neurotransmitter levels like serotonin, noradrenaline, glutamate, nitric oxide and gamma aminobutyric acid, increase in the levels of proinflammatory cytokines and modulate the dopaminergic signaling (Babaie et al., 2017). The behavioral changes produced by the cyst formation in the brain tissue may also related to the localization of the cyst within specific parts of the brain and this is assumed to be one of the main causes of epilepsy in toxoplasmosis. Moreover, tachyzoites may invade the brain tissues and excite brain cells especially neurons, microglia and astrocytes. Additionally, the presence of Toxoplasma in brain evokes inflammatory response and stimulate immune system to produce antibodies with increase in proinflammatory cytokines. Interestingly, some studies described that many host genes and proteins could be affected by Toxoplasma, signifying its involvement in many genetic disorders including neuropsychiatric diseases.The current study aimed to assess the seroprevalence of anti-Toxoplasma IgM and IgG antibodies among children with some neuropsychiatric disorders (Epilepsy and ADHD) in Sohag governorate, Egypt.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case group | – | –45 blood samples will be collected from children have either epilepsy or ADHD. Approximately 3 ml venous blood will be collected from each child by venipuncture, under sterile conditions. |
| Control group | – | –45 blood samples will be collected from matched children for age and gender, served as control. Approximately 3 ml venous blood will be collected from each child by venipuncture, under sterile conditions. |
Who may qualify
- Ages
- Up to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 90 children will be collected from children ,45 of them have either epilepsy or ADHD and another matched 45 children for age and gender, served as control.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Comparison between incidence of Toxoplasma gondii in children with neuropsychiatric disorders and children without neuropsychiatric disorders
Time frame: 6 months
1 secondary outcome
Prevalence of Toxoplasma gondii in children with neuropsychiatric disorders
Time frame: 4 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2025.
- Individual participant dataSharing planned: Undecided
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Toxoplasmosis in Neuropsychiatric Disorders, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: opening soon, as of the sponsor's last update on 20 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alaa Abd Elhamid Elsayed, Demonstrator (+201100546404, alaa.abdelhameed@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison between incidence of Toxoplasma gondii in children with neuropsychiatric disorders and children without neuropsychiatric disorders (time frame: 6 months). 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 20 May 2025.