NCT07471490Enrolling by invitation
Specimen and Data Collection for a Novel Biomarker Combination for the Differential Diagnosis of Inflammatory Bowel Disease and Irritable Bowel Syndrome.
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
Source: ClinicalTrials.gov · Last updated 13 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Observational
- Enrollment
- 300 (estimated)
- First submitted
- 10 Mar 2026
- Start date
- 7 May 2025
- Primary completion date
- 1 Aug 2026
- Lead sponsor
- DiaSorin Inc.
- Diseases
- Ulcerative colitis
- NCT number
- NCT07471490
What you commit to
- Study type: Observational
- Planned participants: 300
- From 7 May 2025 to the primary completion date, 1 Aug 2026
- 2 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- History of IBD, IBS, or other chronic GI disorders
Who the study is looking for
- 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)
Age in the registry: 2 years to - · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| San Rafaelle Hospital Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| University of MN Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.