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Urine Metabolites in the Diagnosis of Disease

Observational Study of Urine Metabolites in the Diagnosis of Disease

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

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)?

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official eligibility 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.

Study sites (4)

CA