Specimen and Data Collection for a Novel Biomarker Combination for the Differential Diagnosis of Inflammatory Bowel Disease and Irritable Bowel Syndrome.
Enrolling by invitation
Conditions studied: IBD (Inflammatory Bowel Disease), IBS (Irritable Bowel Syndrome), Gastrointestinal Symptoms
In brief
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.
Key facts
- Study ID
- NCT07471490
- Run by
- DiaSorin Inc.
- People needed
- 300
- Starts
- 2025-05-07
- Expected to finish
- 2026-09-01
- Last updated by the study team
- 2026-03-13
Who can join
Age: 2 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Able and willing to provide written informed consent, either personally or through a legally authorized representative
- Capable of understanding and complying with the study's stool specimen collection procedures
- For subjects under 18 years of age, enrollment will occur in accordance with applicable US IRB regulations, including informed consent from a parent or guardian and assent from the subject when appropriate (e.g., ages 14-17 years)
You may not qualify if…
- History of IBD, IBS, or other chronic GI disorders
Where it is running
- University of MN — Minneapolis, Minnesota, United States
- San Rafaelle Hospital — Milan, Michigan, Italy
Full record on ClinicalTrials.gov
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