Status:
UNKNOWN
Prospective Multicenter Trial to Determine the Efficacy and Outcome of the UCRI Biomarker Panel and Algorithm to Detect Mucosal Healing in Moderate to Severe Ulcerative Colitis Patients.
Lead Sponsor:
Glycominds, LLC
Collaborating Sponsors:
University of California, Davis
University of California, Irvine
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18-65 years
Brief Summary
The purpose of this research study is to determine the efficacy and outcome of the UCRI (an in-vitro diagnostics device in the form of a blood test and an algorithm) as a tool to detect mucosal healin...
Detailed Description
At the early stage of mucosal inflammation in patients with inflammatory Bowel Diseases (IBD), neutrophils flood into intestinal mucosa, phagocytose pathogenic microbes, and promote mucosal healing an...
Eligibility Criteria
Inclusion
- Ulcerative colitis patients with Mayo Endoscopic Subscore of 2-3
- Start/switch anti -TNFa treatment
- Capable of at-home fCal testing
Exclusion
- Pregnant women
- anti -TNFa dose escalation/adjustment
- Inability to undergo endoscopic assessments due to Proctitis
- Diagnosed with infectious diseases
- Steroid refractory
Key Trial Info
Start Date :
August 24 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04897282
Start Date
August 24 2021
End Date
December 31 2024
Last Update
August 18 2023
Active Locations (1)
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1
UC Davis Inflammatory Bowel Disease Center
Sacramento, California, United States, 95816