Urine Tests to Help Detect Bowel and Digestive Diseases
Studies urine samples to see whether they can help detect several digestive diseases.
Key facts
- Who runs it
- Luventix, Inc.
- Where
- Encinitas, Santa Monica, and Walnut Creek, United StatesSee the 4 sites
- Trial code
- Registry title
- Urine Metabolites in the Diagnosis of Disease
- Status
- Recruiting
- People taking part
- 1,250 people, planned
- Started
- 1 Oct 2024
- Planned end
- Sept 2026
- Type of study
- Observational
- Record updated
- 13 December 2024
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults, with or without certain gut diseases, who can give one urine sample. It tests a urine-based way to find gut diseases.
- Age
- 18 years or older
- Sex
- All sexes can join
Main reasons for not taking part
- Known to be pregnant
- A medical condition that the investigator or sponsor decides rules out joining
The registry criteria, word for word
Show all 5 criteriaShow less
Who can take part
- 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
Who cannot take part
- A medical condition which, in the opinion of the Investigator and/or Sponsor, should preclude enrollment in the study
- Known to be pregnant
Where in United States
- Unio Health Partners (Gastroenterology)Encinitas, United StatesContact: Sarah Marchetti, Practice ManagerTaking people
- Digestive Health AssociatesSanta Monica, United StatesContact: La Juana, Study CoordinatorTaking people
- Westside Gastro CareSanta Monica, United StatesContact: Jennifer, Patient Care CoordinatorTaking people
- Bass Medical Group (Gastroenterology)Walnut Creek, United StatesContact: Stephanie Saxton, Practice Manager, CMATaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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)?
The group in the trial
- Disease Cohort
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Observational Study of Urine Metabolites in the Diagnosis of Disease
- Plain-language title
- Urine Tests to Help Detect Bowel and Digestive DiseasesGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 13 December 2024