Urine Metabolites in the Diagnosis of Disease

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)?

Recruiting

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Key information

Conditions

Colorectal Cancer Celiac Disease Colonic Diseases Colorectal Neoplasms Crohn Disease Digestive System Diseases Digestive System Neoplasms Gastroenteritis Gastrointestinal Diseases Gastrointestinal Neoplasms Inflammatory Bowel Diseases Intestinal Diseases Intestinal Neoplasms Malabsorption Syndromes Metabolic Diseases Neoplasms Neoplasms by Site Nutritional and Metabolic Diseases Rectal Diseases Small Intestinal Bacterial Overgrowth Syndrome (SIBO)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Unio Health Partners (Gastroenterology), Encinitas, California, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Disease signal detection

Time frame: 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

Time frame: From date of enrollment to the end of sample analysis, up to 100 weeks

Sensitivity and specificity/false-positive rate

Study contacts

Contact information is provided by the study sponsor or research team.

Catherine Fine, MS, CGC

CONTACT

[email protected]

888-404-3143

Sponsors and collaborators

Lead sponsor

Luventix, Inc.

Industry

Registry information

Official study title

Observational Study of Urine Metabolites in the Diagnosis of Disease

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2026
First posted: Nov 29, 2024
Registry last updated: Dec 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed