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Urine Metabolites in the Diagnosis of Disease
Observational Study of Urine Metabolites in the Diagnosis of Disease
Who can join
Ages 18 and older · All sexes · Healthy volunteers welcome
Full eligibility criteria
Inclusion Criteria: * Age ≥ 18 years of age at time of enrollment. * Able and willing to provide a one-time urine sample and comply with all study procedures for the study. * Able to understand the study procedures, able to provide consent to participate in the study, and willing to authorize release of relevant protected health information by consenting to a HIPAA medical release form. Exclusion Criteria: * Known to be pregnant. * A medical condition which, in the opinion of the Investigator and/or Sponsor, should preclude enrollment in the study.
About the study
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)?
Sponsor: Luventix, Inc. · Participants: 1,250 · Started: Oct 1, 2024
Contact the study team
- Catherine Fine, MS, CGC · Phone: 888-404-3143
Official record on ClinicalTrials.gov — NCT06710067
Locations in the U.S.
| California | Unio Health Partners (Gastroenterology), Encinitas Digestive Health Associates, Santa Monica Westside Gastro Care, Santa Monica Bass Medical Group (Gastroenterology), Walnut Creek |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.