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.

Status unconfirmed

Conditions studied: Ulcerative Colitis

In brief

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 healing (level of inflammation in the colon) in people with moderate-to-severe ulcerative colitis treated with anti-TNFα. Another reason is to explore additional biomarkers in blood, stool or voice to detect disease activity and/or mucosal healing. A tool to detect the level of inflammation in the colon based on blood, stool or voice biomarkers may reduce the need or the number of invasive endoscopic procedures. This is an observational study and no treatment decision nor clinical intervention will be done based on results during this study and all collected data will be used only for the goal of the study and for obtaining FDA IDE for a follow-up study.

Key facts

Study ID

NCT04897282

Run by

Glycominds, LLC

People needed

100

Starts

2021-08-24

Expected to finish

2024-12-31

Last updated by the study team

2023-08-18

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Ulcerative colitis patients with Mayo Endoscopic Subscore of 2-3
• Start/switch anti -TNFa treatment
• Capable of at-home fCal testing

You may not qualify if…

• Pregnant women
• anti -TNFa dose escalation/adjustment
• Inability to undergo endoscopic assessments due to Proctitis
• Diagnosed with infectious diseases
• Steroid refractory

Where it is running

• UC Davis Inflammatory Bowel Disease Center — Sacramento, California, United States (enrolling)

Full record on ClinicalTrials.gov

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