NCT07500740

Nanobody-based Schistosomiasis Urine Test Kit Research

Screening of IPSE-Specific Nanobodies and Application in the Diagnosis of Schistosoma Haematobium Infection

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 2,500 (estimated)
• Sponsor: Pemba Ministry of Health Zanzibar · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: —

Summary

This study aims to develop and evaluate a nanobody-based urine diagnostic test for Schistosoma haematobium infection through IPSE antigen detection. Approximately 2500 participants will be recruited and divided into five groups: confirmed S. haematobium infection, S. mansoni infection, urinary tract infection, nephritis or other renal diseases, and healthy controls (about 500 individuals per group). Each participant will provide a single morning midstream urine sample (30-50 mL), which will be used both for the development and optimization of the nanobody-based colloidal gold lateral flow assay (LFIA) and for evaluation of its diagnostic performance compared with urine-filtration microscopy.

Conditions

• Schistosomiasis Haematobia

Interventions

Type	Name	Description
OTHER	Because this is an observational study, participants are not assigned an intervention as part of the study.	Because this is an observational study, participants are not assigned an intervention as part of the study.

Timeline

• Start date: 2026-04-01
• Primary completion: 2026-10-01
• Completion: 2026-12-01
• First posted: 2026-03-30
• Last updated: 2026-03-30

Locations

1 site across 1 country: Tanzania