Urine Metabolites in the Diagnosis of Disease

Recruiting

• Conditions: Colorectal Cancer; Crohn Disease; Small Intestinal Bacterial Overgrowth Syndrome (SIBO); Celiac Disease

• Registration Number: NCT06710067
• Lead Sponsor: Luventix, Inc.

Brief 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)?

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-27
• Study Start: 2024-10-01
• Status Verified: 2024-11
• Study First Submitted QC: 2024-11-25
• Study First Posted: 2024-11-29
• Last Update Submitted: 2024-12-11
• Last Update Posted: 2024-12-13
• Primary Completion: 2025-09
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1250

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disease signal detection	From date of enrollment to the end of sample analysis, up to 100 weeks	Disease signal detection quantification within each disease cohort, compared to normal controls.
Test performance measures	From date of enrollment to the end of sample analysis, up to 100 weeks	Sensitivity and specificity/false-positive rate

Trial Locations

Locations (4)

Digestive Health Associates; 🇺🇸 Santa Monica, California, United States

Westside Gastro Care; 🇺🇸 Santa Monica, California, United States

Unio Health Partners (Gastroenterology); 🇺🇸 Encinitas, California, United States

Bass Medical Group (Gastroenterology); 🇺🇸 Walnut Creek, California, United States