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.
Key facts
- Who runs it
- DiaSorin Inc.
- Where
- Minneapolis, United StatesSee the siteAlso in 1 other country, 1 site
- Trial code
- Registry title
- Specimen and Data Collection for a Novel Biomarker Combination for the Differential Diagnosis of Inflammatory Bowel Disease and Irritable Bowel Syndrome.
- Status
- Enrolling by invitation
- People taking part
- 300 people, planned
- Started
- 7 May 2025
- Planned end
- 1 Sept 2026
- Type of study
- Observational, 2 groups
- Record updated
- 13 March 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people aged 2 years and older who are having a colonoscopy as part of routine care and will give a stool sample for a new test.
- Age
- 2 years and older.
- Sex
- All sexes can join.
- Biomarker or test result
- A stool sample is collected for a new calprotectin test (LIAISON® Calprotectin HD).
Main reasons for not taking part
- History of IBD, IBS, or other chronic GI disorders
- Cannot understand or follow the stool sample collection steps
- Cannot give written informed consent, personally or through a legal representative
The registry criteria, word for word
Show all 4 criteriaShow less
Who can take part
- 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)
Who cannot take part
- History of IBD, IBS, or other chronic GI disorders
Where in United States
Also in 1 other country, 1 site
- University of MNMinneapolis, United StatesEnrolling by invitation
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Healthy (normal)
Subjects without history or signs and symptoms of IBS, IBD, or other chronic GI disorders
- Diseased Cohort
Subjects under clinical evaluation for suspected IBD exhibiting persistent lower GI symptoms and undergoing endoscopic evaluation.
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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
- Plain-language title
- A New Stool Test to Tell Inflammatory Bowel Disease From Irritable Bowel SyndromeGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 13 November 2026.
- Record updated
- 13 March 2026