NCT07471490
Specimen and Data Collection for a Novel Biomarker Combination for the Differential Diagnosis of Inflammatory Bowel Disease and Irritable Bowel Syndrome.
Enrolling by Invitation
Not specifiedAges 2+ObservationalDiaSorin Inc.
~300 participants
Updated 2026-03-13 on ClinicalTrials.gov
At a glance
Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Diagnostic Performance
Measured over 1 year
Conditions
Where it's being run
2 sites across 2 statesMinnesota1
Michigan1
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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Eligibility criteria
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
What this trial measures
- Diagnostic Performance1 year
The candidate assay will be compared to standard FC testing in differentiating IBD from non-IBD cases against a predicate (IVDR comparator) device and using the clinical SOC, specifically endoscopic classification as the reference standard.