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ALPCO Calprotectin CLIA Assay for IBD and IBS

This study is testing a new laboratory test called the ALPCO Calprotectin CLIA. This test measures calprotectin, a protein found in stool samples that can show inflammation in your gut. The goal is to see how well this test can help doctors diagnose Inflammatory Bowel Diseases (IBD), like Crohn's Disease and Ulcerative Colitis, and tell them apart from Irritable Bowel Syndrome (IBS). You might be able to join if you are an adult, at least 22 years old, and have symptoms like stomach pain or diarrhea that suggest IBD or IBS. The study aims to enroll 220 participants to gather data on the test's accuracy.

Study design
This is an observational study, meaning researchers will collect information without giving you a specific treatment. It plans to include 220 participants.
What's involved
You would need to provide a stool sample either before a scheduled endoscopy or after a colonoscopy.
Compensation
Not stated in the trial record.
Follow-up
The study will follow participants through study completion, up to 52 weeks.

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NCT06810518

ALPCO Calprotectin CLIA Assay - Measurement of Calprotectin Levels in Human Stool

Recruiting
Not specifiedAges 22+Observational
American Laboratory Products Company
~220 participants
Updated 2026-04-28 on ClinicalTrials.gov
What's tested:ALPCO Calprotectin CLIA

At a glance

Recruiting sites
2 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
In vitro diagnostic value of Calprotectin
Measured over Through study completion, up to 52 weeks.

Conditions

Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis)
Inflammatory Bowel Syndrome

Explore related trials

Crohn DiseaseIrritable Bowel SyndromeUlcerative Colitis

Where it's being run

3 sites across 3 states
Florida1
New Hampshire1
Ohio1

Who to contact

Yomi Ojutalayo
[email protected]
800-592-5726
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Male or female, ≥22 years of age (adults)
Suspected inflammatory bowel disease or irritable bowel syndrome with symptoms such as abdominal pain, diarrhea, altered appetite, weight loss, or anemia
Able to provide a sample according to the sampling protocol within 72-24 hours prior to the scheduled diagnostic endoscopy or 3-30 days after the colonoscopy.
Able to understand the study and the tasks required and sign the ICF

Exclusion

Unable or unwilling to provide a stool specimen
Known active intestinal cancer or in remission with abnormal levels (per physician assessment)
Known active intestinal infection or history of treated intestinal infection with persistent abnormal levels (per physician assessment)
IBD patients receiving chemotherapy or systemic immunosuppressive drugs without completing an 8-week washout period
IBD patients who have previously diagnosed IBD managed with immunomodulators, 5-ASA or biologic therapies without completing an 8-week washout period for biologics and immunomodulators or 4 weeks for 5-ASA
IBD patients who have previously been diagnosed with IBD and have undergone a surgical resection or diversion procedure.
Known upper Gl disease such as esophagitis or gastritis that might influence the study test's ability to detect intestinal inflammatory disease
Have taken NSAIDS (including aspirin) on 7 or more days during the 2 weeks before providing the sample
Samples are not collected according to sampling protocol.
Any condition that in the opinion of the investigator should preclude participation in the study.

What this trial measures

  • In vitro diagnostic value of CalprotectinThrough study completion, up to 52 weeks.

    Value of calprotectin measurement using the ALPCO Calprotectin CLIA on the chemiluminescent automated KleeYa instrument.