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

DiaSorin

Status

Invitation-only

Conditions

IBD (Inflammatory Bowel Disease)

IBS (Irritable Bowel Syndrome)

Gastrointestinal Symptoms

Study type

Observational

Funder types

Industry

Identifiers

NCT07471490

006634

Details and patient eligibility

About

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.

Full description

This study will evaluate the performance of a new stool-based laboratory test, which is designed to help identify inflammatory bowel disease (IBD). The study will compare this new test to standard fecal calprotectin testing. The goal is to determine how accurately the new assay can distinguish IBD from non-IBD conditions when compared with clinical diagnosis based on colonoscopy findings.

Participants will be individuals undergoing routine medical evaluation for symptoms suggestive of IBD. All medical care-including colonoscopy and biopsy collection (if applicable)-will follow standard clinical practice, and no additional procedures will be performed. Each participant will provide a stool sample for testing with the investigational device.

The study will also explore how the new test relates to endoscopic disease severity, microscopic inflammation in ulcerative colitis, and intestinal ultrasound findings. In addition, the study will estimate whether use of the new test could help reduce unnecessary colonoscopies.

This is a prospective, observational, multi-center study enrolling both pediatric and adult participants in the United States and internationally. Results from this study will support regulatory submissions in the United States and Europe.

Enrollment

300 estimated patients

Sex

All

Ages

2+ years old

Volunteers

Accepts Healthy Volunteers

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