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Observational Study on Urine Metabolites for GI Disease Diagnosis

This study is looking for volunteers to help develop a new, non-invasive (meaning it doesn't involve surgery or needles) way to diagnose different gastrointestinal (GI) diseases using a urine sample. Researchers want to see if they can use artificial intelligence to detect specific patterns in your urine that could identify conditions like colorectal cancer, small intestinal bacterial overgrowth (SIBO), Crohn's disease, and Celiac disease. The main goals are to see if this urine test can find a "disease signal" for each condition and how well it performs compared to healthy individuals. You can join if you are at least 18 years old and willing to provide a one-time urine sample.

Study design
This is an observational study, meaning no interventions are given. It aims to enroll 1250 participants.
What's involved
You would need to provide a one-time urine sample and comply with all study procedures. The study involves understanding procedures and providing consent.
Compensation
Not stated in the trial record.
Follow-up
Your samples will be analyzed from the date of enrollment up to 100 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06710067

Urine Metabolites in the Diagnosis of Disease

Recruiting
Not specifiedAges 18+Observational
Luventix, Inc.
~1,250 participants
Updated 2024-12-13 on ClinicalTrials.gov

At a glance

Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Disease signal detection
Measured over From date of enrollment to the end of sample analysis, up to 100 weeks
+1 more outcome measured

Conditions

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

Explore related trials

Celiac DiseaseColorectal CarcinomaCrohn DiseaseSmall intestinal bacterial overgrowth

Where it's being run

4 sites across 1 states
California4

Study leadership

  • John Spinosa, MD, PhD · PRINCIPAL_INVESTIGATOR · Luventix, Inc.

Who to contact

Catherine Fine, MS, CGC
[email protected]
888-404-3143
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Known to be pregnant.
A medical condition which, in the opinion of the Investigator and/or Sponsor, should preclude enrollment in the study.

What this trial measures

  • Disease signal detectionFrom 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 measuresFrom date of enrollment to the end of sample analysis, up to 100 weeks

    Sensitivity and specificity/false-positive rate