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

Specimen and Data Collection for the COMBI Study: A Multi-center, Multi-national Clinical Evaluation of LIAISON® Calprotectin HD, a Novel Biomarker Combination for the Differential Diagnosis of Inflammatory Bowel Disease and Irritable Bowel Syndrome. COMBI: Combination of Markers for Bowel (IBD-IBS) Investigation

Status

Enrolling by invitation

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07471490

Acronym

COMBI

Enrollment

300

Registered

2026-03-13

Start date

2025-05-07

Completion date

2026-09-01

Last updated

2026-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Detailed 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

2 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Diagnostic Performance	1 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.

Countries

Italy, United States

Outcome results