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Urine Metabolites in the Diagnosis of Disease
Sponsor: Luventix, Inc.
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
Conditions
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