Nanobody-based Schistosomiasis Urine Test Kit Research

March 25, 2026 updated by: Pemba Ministry of Health Zanzibar

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

2500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Tanzania
    • CharkChark
      • Pemba, CharkChark, Tanzania, P.O.BOX 98
        • Neglected tropical diseases in Pemba

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

A total of 2500 urine samples will be collected. These samples will be divided into five groups, each consisting of 500 individuals: Healthy control group; Schistosoma haematobium infection group; Schistosoma mansoni infection group; Nephritis patient group; Urinary tract infection patient group.

Description

Inclusion Criteria:

  1. Signed written informed consent must be obtained from the participant. If the participant is a minor or legally incompetent, written informed consent must be obtained from the parent(s) or legal guardian, together with assent from the participant where applicable.
  2. Able to provide a 30-50 mL first-morning midstream urine sample as required and willing to comply with all study-specified procedures, including

1) Index assay: nanobody-based lateral flow chromatography; 2) Reference assay: urine filtration microscopy; 3) Stool Kato-Katz examination if clinically indicated. 3. Complete basic demographic and clinical data (including age, sex, presenting symptoms, medical history, etc.) are available, and the participant has consented to the use of these data for study analysis.

4. Participants must fulfill one of the following group definitions:

  1. S. haematobium infection group: Schistosoma haematobium eggs detected by urine filtration microscopy, with ≥1 egg per 10 mL urine.
  2. S. mansoni infection group: Schistosoma mansoni eggs detected in stool by Kato-Katz thick smear.
  3. Nephritis group: Clinical diagnosis of nephritis supported by abnormal urinalysis (e.g., proteinuria).
  4. Urinary tract infection (UTI) group: Clinical diagnosis of urinary tract infection supported by abnormal urinalysis (e.g., leukocyturia, bacteriuria).
  5. Healthy control group: Negative parasitological test results and no clinical evidence of the aforementioned diseases.

Exclusion Criteria:

  1. Participant did not provide written informed consent or was unable to complete the informed consent process.
  2. Participant is unable to provide a qualified specimen as required:

1) Unable to provide first morning midstream urine; 2) Urine volume < 30 mL; 3) Specimen is obviously contaminated, improperly preserved, or lacks complete labeling; 4) Index assay or reference assay cannot be completed, or results are uninterpretable.

3. Clinical or laboratory data are insufficient to allow for group assignment or subsequent study analysis.

4. Presence of any condition that may significantly interfere with the interpretation of study results (as assessed by the investigator or clinician), including:

  1. Other concurrent, clearly defined severe urinary tract diseases or acute/critical illnesses that preclude differentiation of the cause of abnormal urinalysis parameters;
  2. Recent treatment that may affect parasitological or urinalysis results (e.g., recent antiparasitic therapy, antibiotic therapy, etc.), potentially leading to unreliable group assignment (specific time windows may be defined in the protocol).

5. In the investigator's judgment, the participant is otherwise unsuitable for enrollment or unable to comply with study procedures.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic performance of the LFIA strip, including sensitivity, specificity, positive predictive value, negative predictive value, limit of detection, repeatability, and cross-reactivity, using urine filtration microscopy as the reference method.
Time Frame: At baseline (Day 1), at the time of participant enrollment and urine sample collection, with LFIA testing performed immediately. Diagnostic performance will be assessed based on results obtained at this single time point. The study will commence in April
The diagnostic performance of the LFIA strip, including sensitivity, specificity, positive predictive value, negative predictive value, limit of detection, repeatability, and cross-reactivity, will be evaluated using urine filtration microscopy as the reference standard. Each participant will provide one urine sample at enrollment, and LFIA testing will be performed immediately after sample collection. Diagnostic performance will be assessed based on results obtained at this single time point.
At baseline (Day 1), at the time of participant enrollment and urine sample collection, with LFIA testing performed immediately. Diagnostic performance will be assessed based on results obtained at this single time point. The study will commence in April

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pemba Ministry of Health Zanzibar

Collaborators

Jiangsu Institute of Parasitic Diseases

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)

April 1, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

March 4, 2026

First Submitted That Met QC Criteria

March 25, 2026

First Posted (Actual)

March 30, 2026

Study Record Updates

Last Update Posted (Actual)

March 30, 2026

Last Update Submitted That Met QC Criteria

March 25, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JIPD-2025-007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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