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ENROLLING BY INVITATION
NCT07471490

Specimen and Data Collection for a Novel Biomarker Combination for the Differential Diagnosis of Inflammatory Bowel Disease and Irritable Bowel Syndrome.

Sponsor: DiaSorin Inc.

View on ClinicalTrials.gov

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