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Urine Metabolites in the Diagnosis of Disease

Luventix, Inc. · NCT06710067

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Accepted
Study type
Observational
Target enrollment
1250
US sites recruiting
4
Study start
October 1, 2024
Record last updated
December 13, 2024

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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

  • Does the platform identify a disease signal within each disease cohort, compared to normal controls?
  • How well does the test perform (e.g. sensitivity and specificity/false-positive rate)?

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

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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.

Recruiting US locations

  • Unio Health Partners (Gastroenterology)

    Encinitas, CA 92024

    Site contact: Sarah Marchetti, Practice Manager · 760-783-0441 · sarah.marchetti@uniohp.com

  • Digestive Health Associates

    Santa Monica, CA 90404

    Site contact: La Juana, Study Coordinator · 310-829-6789 · elle20124me@gmail.com

  • Westside Gastro Care

    Santa Monica, CA 90404

    Site contact: Jennifer, Patient Care Coordinator · 310-285-3005 · execassistant@westsidegastrocare.com

  • Bass Medical Group (Gastroenterology)

    Walnut Creek, CA 94598

    Site contact: Stephanie Saxton, Practice Manager, CMA · 925-329-3723 · stephanie.saxton@bassmedicalgroup.com

Study contacts (from the official record)

  • Catherine Fine, MS, CGC · 888-404-3143 · research@luventix.com
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Urine Metabolites in the Diagnosis of Disease (NCT06710067) | Bored Studies