Menu
Recruiting NCT06710067

Urine Metabolites in the Diagnosis of Disease

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

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Colorectal Cancer, Small Intestinal Bacterial Overgrowth Syndrome (SIBO), Crohn Disease, Celiac Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Observational Study of Urine Metabolites in the Diagnosis of Disease

Overview

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)?

Primary outcome measures

  • 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]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

United States · 4 centers
  • Unio Health Partners (Gastroenterology) — Encinitas
  • Digestive Health Associates — Santa Monica
  • Westside Gastro Care — Santa Monica
  • Bass Medical Group (Gastroenterology) — Walnut Creek

Publications

  • Pasikanti KK, Ho PC, Chan EC. Gas chromatography/mass spectrometry in metabolic profiling of biological fluids. J Chromatogr B Analyt Technol Biomed Life Sci. 2008 Aug 15;871(2):202-11. doi: 10.1016/j.jchromb.2008.04.033. Epub 2008 Apr 29. PMID 18479983
  • Dinges SS, Hohm A, Vandergrift LA, Nowak J, Habbel P, Kaltashov IA, Cheng LL. Cancer metabolomic markers in urine: evidence, techniques and recommendations. Nat Rev Urol. 2019 Jun;16(6):339-362. doi: 10.1038/s41585-019-0185-3. PMID 31092915
  • Wittmann BM, Stirdivant SM, Mitchell MW, Wulff JE, McDunn JE, Li Z, Dennis-Barrie A, Neri BP, Milburn MV, Lotan Y, Wolfert RL. Bladder cancer biomarker discovery using global metabolomic profiling of urine. PLoS One. 2014 Dec 26;9(12):e115870. doi: 10.1371/journal.pone.0115870. eCollection 2014. PMID 25541698
  • Fan J, Hong J, Hu JD, Chen JL. Ion chromatography based urine amino Acid profiling applied for diagnosis of gastric cancer. Gastroenterol Res Pract. 2012;2012:474907. doi: 10.1155/2012/474907. Epub 2012 Jul 25. PMID 22888338
  • Issaq HJ, Nativ O, Waybright T, Luke B, Veenstra TD, Issaq EJ, Kravstov A, Mullerad M. Detection of bladder cancer in human urine by metabolomic profiling using high performance liquid chromatography/mass spectrometry. J Urol. 2008 Jun;179(6):2422-6. doi: 10.1016/j.juro.2008.01.084. Epub 2008 Apr 23. PMID 18433783

Identifiers

NCT: NCT06710067 · Luventix-001 · 20242000

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗