Urine Metabolites in the Diagnosis of Disease

Part of paid clinical trials in Encinitas, California.

Sponsor
Luventix, Inc.
Study ID
NCT06710067
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Study Details

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)?

Key Dates

Start date
Oct 1, 2024
Status verified
Nov 2024
Primary completion
Sep 30, 2025
Completion
Sep 30, 2026

Study Design

Enrollment
1,250 participants (estimated)

Arms

  • Arm: Disease Cohort

Primary Outcome Measure

Disease signal detection [ Time Frame: From date of enrollment to the end of sample analysis, up to 100 weeks ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Unio Health Partners (Gastroenterology)EncinitasCalifornia92024
Sarah Marchetti, Practice Manager
[email protected]
760-783-0441
Robert Goldklang, MD
Digestive Health AssociatesSanta MonicaCalifornia90404
La Juana, Study Coordinator
[email protected]
310-829-6789
Rahul Dixit, MD
Westside Gastro CareSanta MonicaCalifornia90404
Jennifer, Patient Care Coordinator
[email protected]
310-285-3005
David Yamini, MD
Bass Medical Group (Gastroenterology)Walnut CreekCalifornia94598
Stephanie Saxton, Practice Manager, CMA
[email protected]
925-329-3723
Rishi Sharma, MD

Find similar trials in Encinitas, CA

By condition
Celiac diseaseColorectal cancerCrohn's disease
By specialty
GastroenterologyAutoimmune diseaseOncologyGI oncologyInflammatory bowel disease
By research site
Unio Health Partners (Gastroenterology)· Encinitas, CADigestive Health Associates· Santa Monica, CAWestside Gastro Care· Santa Monica, CABass Medical Group (Gastroenterology)· Walnut Creek, CA

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