A New Stool Test to Tell Inflammatory Bowel Disease From Irritable Bowel Syndrome
Studies a stool test to tell inflammatory bowel disease from other bowel conditions.
Plain-language title generated from the registry record
Registry title: Specimen and Data Collection for a Novel Biomarker Combination for the Differential Diagnosis of Inflammatory Bowel Disease and Irritable Bowel Syndrome.
Key facts
- Where
- Milan, ItalySee the site
Where in Italy
- San Rafaelle HospitalMilan, ItalyNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- DiaSorin Inc.
- Trial code
- NCT07471490
- Record updated
- 13 March 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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).
Exclusion: History of IBD, IBS, or other chronic GI disorders.