By InvitationNot Applicable

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

United States, Italy300 participantsStarted 2025-05-07

Plain-language summary

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.

Who can participate

Age range2 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * History of IBD, IBS, or other chronic GI disorders

What they're measuring

Diagnostic Performance

Timeframe: 1 year

Trial details

NCT IDNCT07471490

SponsorDiaSorin Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-08-01

View on ClinicalTrials.gov More IBD (Inflammatory Bowel Disease) trials