Recruiting

Observational Study

Sponsor:

Luventix, Inc.

Code:

NCT06710067

Conditions

Colorectal Cancer

Small Intestinal Bacterial Overgrowth Syndrome (SIBO)

Crohn Disease

Celiac Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Study Details

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)?

Conditions

Colorectal Cancer

Small Intestinal Bacterial Overgrowth Syndrome (SIBO)

Crohn Disease

Celiac Disease

Study ID

NCT06710067

Start date

Oct 1, 2024

Status verified date

Nov, 2024

Completion date

Sep, 2026

Anticipated

Primary completion date

Sep, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

1250 participants

Anticipated

Interventions and Outcome Measures

Arms

Disease Cohort

Primary outcome measure

  • Disease signal detection [ Time Frame: From date of enrollment to the end of sample analysis, up to 100 weeks ]
  • Test performance measures [ Time Frame: From date of enrollment to the end of sample analysis, up to 100 weeks ]

Central Contacts and Locations

Central contacts

Catherine Fine, MS, CGC

888-404-3143research@luventix.com

Locations

Unio Health Partners (Gastroenterology)

Recruiting

Encinitas, California, United States, 92024

Contacts

Sarah Marchetti, Practice Manager

760-783-0441sarah.marchetti@uniohp.com

Digestive Health Associates

Recruiting

Santa Monica, California, United States, 90404

Contacts

La Juana, Study Coordinator

310-829-6789elle20124me@gmail.com

Westside Gastro Care

Recruiting

Santa Monica, California, United States, 90404

Contacts

Jennifer, Patient Care Coordinator

310-285-3005execassistant@westsidegastrocare.com

Bass Medical Group (Gastroenterology)

Recruiting

Walnut Creek, California, United States, 94598

Contacts

Stephanie Saxton, Practice Manager, CMA

925-329-3723stephanie.saxton@bassmedicalgroup.com

More Information

Sponsor

Luventix, Inc.

Last update posted

Dec 13, 2024

Last verified

Nov, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Luventix, Inc. on 2024-12-13.