Urine Metabolites in the Diagnosis of Disease

Observational Study of Urine Metabolites in the Diagnosis of Disease

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06710067

Enrollment

1250

Registered

2024-11-29

Start date

2024-10-01

Completion date

2026-09-30

Last updated

2024-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Celiac Disease, Colorectal Cancer, Crohn Disease, Small Intestinal Bacterial Overgrowth Syndrome (SIBO)

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)?

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

United States

Contacts

Primary ContactCatherine Fine, MS, CGC

research@luventix.com888-404-3143

Outcome results