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

NCT07471490 | Enrolling By Invitation

• 1 other identifier: 006634
• Study Type: observational
• Target: 300
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

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

Keywords

IBD; IBS; GI; Calprotectin; Irritable Bowel Syndrome; Inflammatory Bowel Disease; Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• Diagnostic Performance

  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.

  1 year

Other Outcomes (4)

• Correlation with Endoscopic Disease

  1 year

• Correlation with Histological Inflammation in Ulcerative Colitis

  1 year

• Correlation with Intestinal Ultrasound Findings

  1 year

Study Arms (2)

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.

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects without a diagnosis or signs/symptoms of IBD, IBS, or other chronic gastrointestinal disorders will be enrolled exclusively at selected sites.

You may qualify if:

• 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)

You may not qualify if:

• History of IBD, IBS, or other chronic GI disorders

Sponsors & Collaborators

• DiaSorin Inc.: lead

Study Sites (2)

University of MN

Minneapolis, Minnesota, 55455, United States

Location

San Rafaelle Hospital

Milan, Michigan, 20132, Italy

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Stool, Blood Products (if applicable)

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Irritable Bowel Syndrome; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Colitis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Days
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2026
• First Posted: March 13, 2026
• Study Start: May 7, 2025
• Primary Completion: August 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1); US (1)