ToxoplasmosisNCT07346833
Role of Circulating MicroRNAs in Differentiating Psychological Disorders Among Women With Chronic Toxoplasmosis
An observational study of Toxoplasmosis, run by Benha University at 1 site in Egypt.
Trial summary
Chronic Toxoplasma gondii (T. gondii) infection is a widespread condition that can negatively affect brain function and is considered a risk factor for various psychiatric conditions, including depression and schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Toxoplasmosis
- What is being tested?
- Circulating miRNA Expression and T. gondii Serology
- How many people
- 55 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Nov 2025to Apr 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 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: The study population consists of adult women (aged 18 years and older) who have been clinically diagnosed with Schizophrenia, Major Depressive Disorder, or Bipolar Disorder according to DSM-5 criteria. These patients are recruited from the psychiatric departments of Benha and Tanta Universities. Within this group, the population is divided into two cohorts: those with chronic toxoplasmosis (confirmed by the presence of anti-Toxoplasma IgG antibodies) and those without the infection. To ensure a specific focus on chronic cases, the study excludes patients with acute toxoplasmosis (IgM positive) or other unrelated psychiatric conditions. No healthy volunteers are included, as the research specifically aims to differentiate biomarkers among patients already experiencing psychological disturbances.
Who may be able to join
- Confirmed psychiatric diagnosis of Schizophrenia (SCZ), Major Depressive Disorder (MDD), or Bipolar Disorder (BD) according to DSM-5 criteria.
- Seronegative for T. gondii IgM (to ensure infection is not in the acute phase).
- Signed informed consent.
Who cannot join
- Psychiatric disorders other than Schizophrenia, MDD, and Bipolar Disorder.
- Seropositive for T. gondii IgM (indicating acute infection).
- Refusal to participate.
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, 1 recruiting
- Recruiting
Benha faculty of Medicine
Banhā, El Qalyoubia, 13511
Hesham Rashid, Professor, 101 497 7666 ext. +20, b.checked88@gmail.com
About this study
Official title: Deciphering The Role of Circulating MicroRNAs To Differentiate Psychological Disorders Among Women With Chronic Toxoplasmosis
Chronic Toxoplasma gondii (T. gondii) infection is a widespread condition that can negatively affect brain function and is considered a risk factor for various psychiatric conditions, including depression and schizophrenia. This prospective observational study aims to investigate the expression levels of specific circulating microRNAs (miRNAs) in women diagnosed with schizophrenia, major depressive disorder, or bipolar disorder who also have chronic toxoplasmosis. By comparing these levels to patients without the infection, the study seeks to determine if these miRNAs can serve as biological markers to help differentiate between specific psychological disorders and identify the impact of chronic toxoplasmosis on mental health.
- Conditions
- Toxoplasmosis
- Being tested
- Circulating miRNA Expression and T. gondii Serology
- Medical subject headings
- Toxoplasmosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Circulating miRNA Expression and T. gondii SerologyDiagnostic test
Serology: ELISA testing to detect anti-Toxoplasma IgG (confirming chronic infection) and IgM (excluding acute infection).
Genetic Analysis: Quantitative Reverse-transcriptase PCR (qRT-PCR) to measure the expression levels of a predetermined panel of plasma miRNAs.
Psychiatric Evaluation: Clinical diagnosis according to DSM-5 criteria.
| Study group | Role | What they receive |
|---|---|---|
| T. gondii Seropositive Group | Women with diagnosed psychiatric disorders (Schizophrenia, MDD, or Bipolar Disorder) who test positive for anti-Toxoplasma IgG antibodies, indicating chronic infection. Receives: Diagnostic Test: Circulating miRNA Expression and T. gondii Serology | |
| T. gondii Seronegative Group | Women with the same diagnosed psychiatric disorders who test negative for anti-Toxoplasma IgG antibodies Receives: Diagnostic Test: Circulating miRNA Expression and T. gondii Serology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Accuracy of Plasma miRNA Expression for Detecting Chronic Toxoplasmosis in Psychiatric Patients
The Area Under the Receiver Operating Characteristic (ROC) Curve (AUC) used to determine the diagnostic performance of circulating microRNA fold-change (measured by qRT-PCR) in discriminating between patients with and without chronic T. gondii infection (confirmed by anti-Toxoplasma IgG ELISA).
Measured: 2-3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start20 Nov 2025
- Primary completionFeb 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ToxoplasmosisStudies of the same condition, open and under way.
- More trials run by Benha 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heba M. Aboelela, Benha University
- Investigators
- Basma Salem, MD, Principal investigator, Assistant Professor Clinical and Chemical Pathology. Faculty of Medicine, Benha University, EgyptDina Abd El hadi, MD, Principal investigator, Assistant Professor Medical Parasitology. Faculty of Medicine, Benha University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07346833
- Sponsor's protocol ID
- RC 10.10.2025
- Status last verified
- Jan 2026
- First submitted
- 21 Dec 2025
- Last updated
- 16 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deciphering The Role of Circulating MicroRNAs To Differentiate Psychological Disorders Among Women With Chronic Toxoplasmosis
- ClinicalTrials.gov ID
- NCT07346833
- Acronym / sponsor ID
- RC 10.10.2025
- Conditions
- Toxoplasmosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 20 Nov 2025 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 16 Jan 2026 (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.
Chronic Toxoplasma gondii (T. gondii) infection is a widespread condition that can negatively affect brain function and is considered a risk factor for various psychiatric conditions, including depression and schizophrenia. This prospective observational study aims to investigate the expression levels of specific circulating microRNAs (miRNAs) in women diagnosed with schizophrenia, major depressive disorder, or bipolar disorder who also have chronic toxoplasmosis. By comparing these levels to patients without the infection, the study seeks to determine if these miRNAs can serve as biological markers to help differentiate between specific psychological disorders and identify the impact of chronic toxoplasmosis on mental health.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| T. gondii Seropositive Group | – | Diagnostic Test: Circulating miRNA Expression and T. gondii SerologyWomen with diagnosed psychiatric disorders (Schizophrenia, MDD, or Bipolar Disorder) who test positive for anti-Toxoplasma IgG antibodies, indicating chronic infection. |
| T. gondii Seronegative Group | – | Diagnostic Test: Circulating miRNA Expression and T. gondii SerologyWomen with the same diagnosed psychiatric disorders who test negative for anti-Toxoplasma IgG antibodies |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The study population consists of adult women (aged 18 years and older) who have been clinically diagnosed with Schizophrenia, Major Depressive Disorder, or Bipolar Disorder according to DSM-5 criteria. These patients are recruited from the psychiatric departments of Benha and Tanta Universities. Within this group, the population is divided into two cohorts: those with chronic toxoplasmosis (confirmed by the presence of anti-Toxoplasma IgG antibodies) and those without the infection. To ensure a specific focus on chronic cases, the study excludes patients with acute toxoplasmosis (IgM positive) or other unrelated psychiatric conditions. No healthy volunteers are included, as the research specifically aims to differentiate biomarkers among patients already experiencing psychological disturbances.
Key inclusion criteria (3 listed)
- Confirmed psychiatric diagnosis of Schizophrenia (SCZ), Major Depressive Disorder (MDD), or Bipolar Disorder (BD) according to DSM-5 criteria.
- Seronegative for T. gondii IgM (to ensure infection is not in the acute phase).
- Signed informed consent.
Key exclusion criteria (3 listed)
- Psychiatric disorders other than Schizophrenia, MDD, and Bipolar Disorder.
- Seropositive for T. gondii IgM (indicating acute infection).
- Refusal to participate.
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 |
|---|---|---|
| Circulating miRNA Expression and T. gondii SerologySerology: ELISA testing to detect anti-Toxoplasma IgG (confirming chronic infection) and IgM (excluding acute infection). Genetic Analysis: Quantitative Reverse-transcriptase PCR (qRT-PCR) to measure the expression levels of a predetermined panel of plasma miRNAs. Psychiatric Evaluation: Clinical diagnosis according to DSM-5 criteria. | Diagnostic test | T. gondii Seronegative Group, T. gondii Seropositive Group |
Primary outcome
Diagnostic Accuracy of Plasma miRNA Expression for Detecting Chronic Toxoplasmosis in Psychiatric Patients
Time frame: 2-3 Months
The Area Under the Receiver Operating Characteristic (ROC) Curve (AUC) used to determine the diagnostic performance of circulating microRNA fold-change (measured by qRT-PCR) in discriminating between patients with and without chronic T. gondii infection (confirmed by anti-Toxoplasma IgG ELISA).
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 16 Jan 2026.
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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.
Basma Salem, MD principal investigator
Assistant Professor Clinical and Chemical Pathology. Faculty of Medicine, Benha University, Egypt
Dina Abd El hadi, MD principal investigator
Assistant Professor Medical Parasitology. Faculty of Medicine, Benha University, Egypt
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, run by Benha 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?
The sponsor lists 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 16 Jan 2026. 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 Heba Abo El Ela, MD (01062702236 ext. +2, b.checked88@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Accuracy of Plasma miRNA Expression for Detecting Chronic Toxoplasmosis in Psychiatric Patients (time frame: 2-3 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 16 Jan 2026.