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

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.

NCT Number	NCT07471490
Lead Sponsor	DiaSorin Inc.
Conditions	IBD (Inflammatory Bowel Disease), IBS (Irritable Bowel Syndrome), Gastrointestinal Symptoms
Enrollment	300 participants
Start Date	2025-05-07
Primary Completion	2026-08-01 (estimated)
Study Completion	2026-09-01 (estimated)
Updated on ClinicalTrials.gov	2026-03-13