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Urine Metabolites in the Diagnosis of Disease

Investigating Urine-Based Diagnostic Tool for GI Diseases

Recruiting
18 years and older
All
Phase N/A

This study investigates a non-invasive, urine-based diagnostic technology designed to detect and differentiate various gastrointestinal (GI) diseases. The purpose is to validate this technology in identifying specific GI conditions such as colorectal cancer, small intestinal bacterial overgrowth (SIBO), Crohn's disease, and Celiac disease. An observational study is a type of research study where data is collected by observing participants receiving routine care, without changing their treatment, which may focus on people using specific medications or having certain conditions to better understand how treatments work.

Participants will provide a one-time urine sample and relevant clinical data. The study uses artificial intelligence and machine learning to develop models that can accurately identify and differentiate between different GI diseases. The performance of the test will be evaluated based on its sensitivity and specificity, as well as its ability to correctly identify disease signals in participants compared to normal controls.

  • Who can participate: Adults 18 years or older who can provide a urine sample and comply with study procedures are eligible. Pregnant individuals or those with a medical condition that precludes participation are excluded.
  • Study details: Participants must provide a urine sample and agree to the release of relevant health information. They must comply with study procedures and consent to participate.
  • Study visits: The study requires 1 visit.
Study details
    Colorectal Cancer
    Small Intestinal Bacterial Overgrowth Syndrome (SIBO)
    Crohn Disease
    Celiac Disease

NCT06710067

Luventix, Inc.

17 April 2026

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