Using urine samples to diagnose gastrointestinal diseases

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to validate a non-invasive urine-based diagnostic technology for detecting and differentiating various gastrointestinal diseases, including colorectal cancer, SIBO, Crohn's disease, and Celiac disease. Participants will provide urine samples and clinical data, which will be analyzed using artificial intelligence and machine learning to develop disease-specific models. The study seeks to determine the effectiveness of this platform in identifying disease signals compared to normal controls and to evaluate its performance metrics such as sensitivity and specificity.

Why it matters

Who can join: the full rules

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.

Where it's running

• Unio Health Partners (Gastroenterology)
  Encinitas, California, United States Recruiting
• Digestive Health Associates
  Santa Monica, California, United States Recruiting
• Westside Gastro Care
  Santa Monica, California, United States Recruiting
• Bass Medical Group (Gastroenterology)
  Walnut Creek, California, United States Recruiting

Study contacts

• Principal investigator: John Spinosa, MD, PhD — Luventix, Inc.
• Study coordinator: Catherine Fine, MS, CGC
• Email: research@luventix.com
• Phone: 888-404-3143

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.