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Specimen and Data Collection for a Novel Biomarker Combination for the Differential Diagnosis of Inflammatory Bowel Disease and Irritable Bowel Syndrome.
Sponsor: DiaSorin Inc.
Summary
This study will evaluate how well the a new stool test can distinguish inflammatory bowel disease (IBD) from non-IBD conditions compared with standard calprotectin testing and colonoscopy findings. Participants will undergo only routine clinical care, including colonoscopy, and will provide a stool sample for testing. The study will also examine how test results relate to endoscopic, histologic, and ultrasound measures of disease activity. Findings may help determine whether the new test could reduce unnecessary colonoscopies and support future regulatory submissions.
Official title: Specimen and Data Collection for the COMBI Study: A Multi-center, Multi-national Clinical Evaluation of LIAISON® Calprotectin HD, a Novel Biomarker Combination for the Differential Diagnosis of Inflammatory Bowel Disease and Irritable Bowel Syndrome. COMBI: Combination of Markers for Bowel (IBD-IBS) Investigation
Key Details
Gender
All
Age Range
2 Years - Any
Study Type
OBSERVATIONAL
Enrollment
300
Start Date
2025-05-07
Completion Date
2026-09-01
Last Updated
2026-03-13
Healthy Volunteers
Yes
Locations (2)
University of MN
Minneapolis, Minnesota, United States
San Rafaelle Hospital
Milan, Michigan, Italy