Specimen and Data Collection for a Novel Biomarker Combination for the Differential Diagnosis of Inflammatory Bowel Disease and Irritable Bowel Syndrome.

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
DiaSorin Inc.
Study ID
NCT07471490
Status
Enrolling By Invitation

Conditions

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

Eligibility Criteria

Sex
ALL
Age
2 Years - N/A
Healthy Volunteers
Accepted

Study Details

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.

Key Dates

Start date
May 7, 2025
Status verified
Mar 2026
Primary completion
Aug 1, 2026
Completion
Sep 1, 2026

Study Design

Enrollment
300 participants (estimated)

Arms

  • Arm: Healthy (normal)
    Subjects without history or signs and symptoms of IBS, IBD, or other chronic GI disorders
  • Arm: Diseased Cohort
    Subjects under clinical evaluation for suspected IBD exhibiting persistent lower GI symptoms and undergoing endoscopic evaluation.

Primary Outcome Measure

Diagnostic Performance [ Time Frame: 1 year ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of MNMinneapolisMinnesota55455-

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By research site
University of MN· Minneapolis, MN

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