IBD (Inflammatory Bowel Disease)COMBINCT07471490
Specimen and Data Collection for a Novel Biomarker Combination for the Differential Diagnosis of Inflammatory Bowel Disease and Irritable Bowel Syndrome.
An observational study of IBD (Inflammatory Bowel Disease) and IBS (Irritable Bowel Syndrome), run by DiaSorin Inc. at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 years and olderHealthy volunteers can take part
- Conditions the study is for
- IBD (Inflammatory Bowel Disease), IBS (Irritable Bowel Syndrome), Gastrointestinal Symptoms
- How many people
- 300 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 7 May 2025to 1 Sep 2026
- How long will I take part?
- 3 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Subjects without a diagnosis or signs/symptoms of IBD, IBS, or other chronic gastrointestinal disorders will be enrolled exclusively at selected sites.
Who may be able to join
- 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)
Who cannot join
- History of IBD, IBS, or other chronic GI disorders
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
About this study
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
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.
Read the 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.
- Conditions
- IBD (Inflammatory Bowel Disease), IBS (Irritable Bowel Syndrome), Gastrointestinal Symptoms
- Keywords
- IBD, IBS, GI, Calprotectin, Irritable Bowel Syndrome, Inflammatory Bowel Disease, Ulcerative Colitis
- Medical subject headings
- Inflammatory Bowel Diseases, Irritable Bowel Syndrome, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start7 May 2025
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IBD (Inflammatory Bowel Disease)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 3 Days
Sponsor and investigators
- Lead sponsor
- DiaSorin Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07471490
- Sponsor's protocol ID
- 006634
- Acronym
- COMBI
- Status last verified
- Mar 2026
- First submitted
- 10 Mar 2026
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared but a submission will be provided to FDA
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07471490
- Acronym / sponsor ID
- COMBI / 006634
- Conditions
- IBD (Inflammatory Bowel Disease), IBS (Irritable Bowel Syndrome), Gastrointestinal Symptoms
- Keywords
- IBD, IBS, GI, Calprotectin, Irritable Bowel Syndrome, Inflammatory Bowel Disease, Ulcerative Colitis
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- DiaSorin Inc.Industry (pharma, biotech, devices)
- Study start
- 7 May 2025 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 13 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects without a diagnosis or signs/symptoms of IBD, IBS, or other chronic gastrointestinal disorders will be enrolled exclusively at selected sites.
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (1 listed)
- History of IBD, IBS, or other chronic GI disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic Performance
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Individual participant dataSharing planned: No. IPD will not be shared but a submission will be provided to FDA
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of IBD (Inflammatory Bowel Disease) and IBS (Irritable Bowel Syndrome), run by DiaSorin Inc. at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Performance (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.