Urine Metabolites in the Diagnosis of Disease
Observational · No treatment assigned · 4 sites · Luventix, Inc.
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Colorectal Cancer, Small Intestinal Bacterial Overgrowth Syndrome (SIBO) and Crohn Disease. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 18 and older
- Any sex
- Healthy volunteers accepted
Some of the main requirements, copied from the record:
- 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.
There are also 2 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 1250 participants are expected to take part.
- Start date: 2024-10-01.
- Main results expected around 2025-09 (estimate from the record).
- 4 study sites listed (4 marked recruiting) in United States.
Main thing being measured
- Disease signal detection (From date of enrollment to the end of sample analysis, up to 100 weeks)
In the researchers’ words
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…
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Colorectal Cancer; Small Intestinal Bacterial Overgrowth Syndrome (SIBO); Crohn Disease; Celiac Disease |
| Lead sponsor | Luventix, Inc. |
| Enrollment | 1250 (estimated) |
| Start date | 2024-10-01 |
| Primary completion (est.) | 2025-09 |
| First posted | 2024-11-29 |
| Last updated | 2024-12-13 |
| Official title | Observational Study of Urine Metabolites in the Diagnosis of Disease |
| ClinicalTrials.gov ID | NCT06710067 |
Interventions
- None listed
Full eligibility criteria (from the record)
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.
Locations (4)
| Site | City | Country | Site status |
|---|---|---|---|
| Unio Health Partners (Gastroenterology) | Encinitas, California | United States | Recruiting |
| Digestive Health Associates | Santa Monica, California | United States | Recruiting |
| Westside Gastro Care | Santa Monica, California | United States | Recruiting |
| Bass Medical Group (Gastroenterology) | Walnut Creek, California | United States | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.