Observational Study of Urine Metabolites in the Diagnosis of Disease

Status: Recruiting
Location: See all (4) locations...
Study Type: Observational
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)?

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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.

Locations
United States
California
Unio Health Partners (Gastroenterology)
RECRUITING
Encinitas
Digestive Health Associates
RECRUITING
Santa Monica
Westside Gastro Care
RECRUITING
Santa Monica
Bass Medical Group (Gastroenterology)
RECRUITING
Walnut Creek
Contact Information
Primary
Catherine Fine, MS, CGC
research@luventix.com
888-404-3143
Time Frame
Start Date: 2024-10-01
Estimated Completion Date: 2026-09
Participants
Target number of participants: 1250
Treatments
Disease Cohort
Sponsors
Leads: Luventix, Inc.

This content was sourced from clinicaltrials.gov