Evaluating a blood test to detect mucosal healing in ulcerative colitis patients
Prospective Multicenter Trial to Determine the Efficacy and Outcome of the UCRI In-vitro Diagnostics Device to Detect Treatment Response Measured by Endoscopic Healing in Moderate to Severe Ulcerative Colitis Patients Treated With Anti-TNF-a.
This study is testing a new blood test to see if it can help people with moderate to severe ulcerative colitis know if their treatment is working without needing invasive procedures.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Glycominds, LLC Industry-sponsored |
| Drugs / interventions | infliximab, adalimumab, golimumab |
| Locations | 1 site (Sacramento, California) |
| Trial ID | NCT04897282 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the efficacy of the UCRI biomarker panel and algorithm in detecting mucosal healing in patients with moderate to severe ulcerative colitis who are being treated with anti-TNFα therapy. The study will explore various biomarkers found in blood, stool, or voice to monitor disease activity and mucosal healing, potentially reducing the need for invasive endoscopic procedures. Data collected will be used solely for the study's objectives and to support FDA IDE application for future research.
Who should consider this trial
Good fit: Ideal candidates include ulcerative colitis patients with a Mayo Endoscopic Subscore of 2-3 who are starting or switching anti-TNFα treatment.
Not a fit: Patients who are pregnant, have infectious diseases, or are steroid refractory may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a non-invasive method for monitoring mucosal healing in ulcerative colitis patients, improving patient management.
How similar studies have performed: While the approach of using biomarkers for mucosal healing is emerging, this specific application of the UCRI panel is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Ulcerative colitis patients with Mayo Endoscopic Subscore of 2-3 * Start/switch anti -TNFa treatment * Capable of at-home fCal testing Exclusion Criteria: * Pregnant women * anti -TNFa dose escalation/adjustment * Inability to undergo endoscopic assessments due to Proctitis * Diagnosed with infectious diseases * Steroid refractory
Where this trial is running
Sacramento, California
- UC Davis Inflammatory Bowel Disease Center — Sacramento, California, United States (Recruiting)
Study contacts
- Study coordinator: Avinoam A Dukler, PhD
- Email: ucri@glycominds.com
- Phone: 8057912094
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.