Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
NCT06710067

Urine Metabolites in the Diagnosis of Disease

Led by Luventix, Inc. · Updated on 2024-12-13

1250

Participants Needed

4

Research Sites

100 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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)?

CONDITIONS

Official Title

Urine Metabolites in the Diagnosis of Disease

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older at time of enrollment
  • Able and willing to provide a one-time urine sample and comply with all study procedures
  • Able to understand the study procedures, provide consent, and authorize release of relevant health information by HIPAA medical release form
Not Eligible

You will not qualify if you...

  • Known to be pregnant
  • Any medical condition that, in the opinion of the Investigator or Sponsor, should prevent enrollment in the study

AI-Screening

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Trial Site Locations

Total: 4 locations

1

Unio Health Partners (Gastroenterology)

Encinitas, California, United States, 92024

Actively Recruiting

2

Digestive Health Associates

Santa Monica, California, United States, 90404

Actively Recruiting

3

Westside Gastro Care

Santa Monica, California, United States, 90404

Actively Recruiting

4

Bass Medical Group (Gastroenterology)

Walnut Creek, California, United States, 94598

Actively Recruiting

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Research Team

C

Catherine Fine, MS, CGC

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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