ClinicalTrials.gg
Not yet recruitingNCT06980298Updated May 20, 2025

Toxoplasma Gondii Seroprevalence Among Children With Some Neuropsychiatric Disorders

An observational study in Toxoplasmosis in Neuropsychiatric Disorders, sponsored by Sohag University. Not yet recruiting at 1 site in Egypt. Open to participants aged Up to 15 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-20.

Sponsored by Sohag University · Observational

From the registry’s dates

  • Primary completion was expected by Oct 2025, 1 year 1 month ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
90
Ages
Up to 15 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Toxoplasmosis in Neuropsychiatric Disorders

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03

In context

Toxoplasmosis

29 studies on the registry are indexed under Toxoplasmosis; 8 are open to participants now.

This study's planned enrollment of 90 is close to the median of 100 across 10 observational studies indexed under Toxoplasmosis.

Browse Toxoplasmosis studies →

Lead sponsor

Sohag University is the lead sponsor of 1,230 studies on the registry; 636 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 15 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

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 criteria

Inclusion criteria: Children with neuropsychiatric disorders (epilepsy,ADHD). Exclusion criteria: Children with history of neurosurgery, head injury or trauma, neoplastic or diseases, or receiving or systemic , and those with possible neurological infection.

Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
90 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. Comparison between incidence of Toxoplasma gondii in children with neuropsychiatric disorders and children without neuropsychiatric disorders

    Time frame: 6 months

Secondary outcomes

  1. Prevalence of Toxoplasma gondii in children with neuropsychiatric disorders

    Time frame: 4 months

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jun 2025; primary completion for Oct 2025, 4 months later.

How these figures are worked out, and which studies are left out of them.

Registered
May 12, 2025
First posted
May 20, 2025
StartEst.
Jun 2025
Primary completionEst.
Oct 2025
CompletionEst.
Feb 2026
Last update
May 20, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 20, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06980298
Lead sponsor
Sohag University
Responsible party
Alaa Abdelhameed Elsayed (Alaa Abd Elhamid Elsayed Mohamed, Sohag University) — Principal investigator
First posted
May 20, 2025
Start date
Jun 2025 (estimated)
Primary completion
Oct 2025 (estimated)
Completion
Feb 2026 (estimated)
Last update
May 20, 2025

Study contacts

Alaa Abd Elhamid Elsayed, Demonstrator
Contact
alaa.abdelhameed@med.sohag.edu.eg
+201100546404

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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