- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07482215
Prevalence and Molecular Identification of Human Schistosomiasis
March 16, 2026 updated by: Intesar Heshmat Yousef, Assiut University
Prevalence and Molecular Identification of Human Schistosomiasis With Assessment of Associated Epidemiological Risk Factors in Assiut Governorate, Egypt
Schistosomiasis remains one of the most important parasitic diseases of public health concern, particularly in developing countries including Egypt.
It is caused by a trematode worm (blood flukes) of the genus Schistosoma
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
Schistosomiasis has been diagnosed in Egypt since pharaonic times (3200 B.C.) by recovering Schistosome eggs and antigens in ancient mummies.In Egypt, Schistosoma mansoni and Schistosoma haematobium have historically been highly endemic, with widespread distribution along the Nile Delta and Valley.(4)
Schistosoma haematobium is responsible for urogenital schistosomiasis, with hematuria as its primary manifestation, while Schistosoma mansoni, the prevalent species in Egypt, is causing intestinal schistosomiasis with liver-related sequelae
Study Type
Observational
Enrollment (Estimated)
359
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
N/A
Sampling Method
Probability Sample
Study Population
All participants presented in Assiut Governorate hospitals
Description
Inclusion Criteria:
- Patients aged ≥ 5 years of both sexes attending Assiut Governorate hospitals during the study period.
- Patients clinically suspected of having schistosomiasis (urinary and/or intestinal) or referred for parasitological examination.
- Individuals (or guardians, in case of minors) who provide written informed consent.
- Patients willing to provide the required biological samples (urine and/or stool).
Exclusion Criteria:
- Patients Received praziquantel within the last 3 months before sample collection
- Patients with incomplete clinical or epidemiological data.
- Patients refusing participation or sample collection.
- Improperly collected, contaminated, or insufficient samples.
- Patients suffering from severe comorbid conditions that may interfere with the interpretation of results (e.g., advanced hepatic or renal failure).
- children with congenital urinary or intestinal 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 |
|---|---|
|
Schistosoma haematobium
Urine filtration technique (10 ml urine) for diagnosis
|
DNA Sequencing and cox1 Gene Analysis of Schistosoma Isolates
|
|
Schistosoma mansoni
Direct wet mount and Kato-Katz thick smear technique (stool) for diagnosis
|
DNA Sequencing and cox1 Gene Analysis of Schistosoma Isolates
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
prevalence of human schistosomiasis in the study participants
Time Frame: 24 hours
|
using conventional microscopic examination
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Estimated)
May 1, 2026
Primary Completion (Estimated)
August 1, 2027
Study Completion (Estimated)
December 1, 2027
Study Registration Dates
First Submitted
March 16, 2026
First Submitted That Met QC Criteria
March 16, 2026
First Posted (Actual)
March 19, 2026
Study Record Updates
Last Update Posted (Actual)
March 19, 2026
Last Update Submitted That Met QC Criteria
March 16, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PMHS
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.
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