Using urine samples to diagnose gastrointestinal diseases
Observational Study of Urine Metabolites in the Diagnosis of Disease
Luventix, Inc. · NCT06710067
This study is testing a new way to use urine samples to see if it can help diagnose different gastrointestinal diseases like colorectal cancer and Crohn's disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1250 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Luventix, Inc. (industry) |
| Locations | 4 sites (Encinitas, California and 3 other locations) |
| Trial ID | NCT06710067 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are willing to provide a urine sample and comply with study procedures.
Not a fit: Patients who are pregnant or have medical conditions that would preclude their participation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a more accurate and non-invasive method for diagnosing gastrointestinal diseases.
How similar studies have performed: While the approach of using urine metabolites for disease diagnosis is innovative, similar studies have shown promise in other areas, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Encinitas, California and 3 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Colorectal Cancer, Small Intestinal Bacterial Overgrowth Syndrome, Crohn Disease, Celiac Disease