Specimen and Data Collection for a Novel Biomarker Combination for the Differential Diagnosis of Inflammatory Bowel Disease and Irritable Bowel Syndrome.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: IBD (Inflammatory Bowel Disease), IBS (Irritable Bowel Syndrome), Gastrointestinal Symptoms. Basic parameters: from 2 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Primary outcome measures
- Diagnostic Performance [Time frame: 1 year]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- University of MN — Minneapolis
Italy · 1 center
- San Rafaelle Hospital — Milan
Identifiers
NCT: NCT07471490 · 006634