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RECRUITING
NCT06710067

Urine Metabolites in the Diagnosis of Disease

Sponsor: Luventix, Inc.

View on ClinicalTrials.gov

Summary

The goal of this observational study is to validate a non-invasive, urine-based diagnostic technology for the detection and differentiation of various gastrointestinal (GI) diseases. This research study intends to enroll participants across a range of demographics and GI disease states including colorectal cancer, small intestinal bacterial overgrowth (SIBO), Crohn\'s disease, and Celiac disease, collect urine samples and clinical data, and use artificial intelligence and machine learning to build disease-specific models which can identify and differentiate a participants' specific GI disease. The main questions it aims to answer are: 1. Does the platform identify a disease signal within each disease cohort, compared to normal controls? 2. How well does the test perform (e.g. sensitivity and specificity/false-positive rate)?

Official title: Observational Study of Urine Metabolites in the Diagnosis of Disease

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

1250

Start Date

2024-10-01

Completion Date

2026-09

Last Updated

2024-12-13

Healthy Volunteers

Yes

Locations (4)

Unio Health Partners (Gastroenterology)

Encinitas, California, United States

Digestive Health Associates

Santa Monica, California, United States

Westside Gastro Care

Santa Monica, California, United States

Bass Medical Group (Gastroenterology)

Walnut Creek, California, United States