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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+Observational
DiaSorin 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

IBD (Inflammatory Bowel Disease)
IBS (Irritable Bowel Syndrome)
Gastrointestinal Symptoms

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Gastrointestinal symptom

NCT07471490

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • San Rafaelle Hospital

    Milan, Michigan, Italyno site contact published

  • University of MN

    Minneapolis, Minnesotano site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Want this trial checked against your situation?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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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.