Testing a stool sample test to diagnose bowel inflammation

Plain-English translation of NCT06810518 on ClinicalTrials.gov ↗ · Source last updated April 2026 · Translation generated June 2026 · How we translate trials

What is this trial?

Researchers are testing a new stool test called the ALPCO Calprotectin CLIA assay that measures inflammation markers in your stool sample. The goal is to see whether this simple test can help doctors accurately diagnose inflammatory bowel disease (like Crohn's disease or ulcerative colitis) and tell it apart from irritable bowel syndrome, which is less serious but has similar symptoms.

Right now, doctors often need to perform invasive procedures like colonoscopies to diagnose inflammatory bowel disease. This study exists to see whether a simple stool test could help doctors decide who truly needs those more invasive procedures, making diagnosis faster and easier for patients with stomach pain, diarrhea, and other digestive symptoms.

Do you qualify?

You likely qualify if…

you are at least 22 years old
you have symptoms like abdominal pain, diarrhea, weight loss, or anemia that could suggest inflammatory bowel disease or irritable bowel syndrome
you are able to provide a stool sample within 72 hours before a scheduled colonoscopy or within 3–30 days after one
you can understand the study requirements and sign a consent form

You likely don't qualify if…

you are unable or unwilling to provide a stool sample
you have a history of intestinal cancer or active intestinal infection with ongoing abnormal levels
you have taken NSAIDs or aspirin on 7 or more days in the 2 weeks before your sample collection
you are currently taking immunosuppressive drugs, biologics, or other IBD medications without completing a required washout period (4–8 weeks depending on the drug)

What participation looks like

You would provide a stool sample according to the study's instructions, timed either shortly before or after a colonoscopy that your doctor has already scheduled. The researchers will compare your stool test results with your doctor's diagnosis (based on the colonoscopy and other clinical findings) to see how accurate the new test is. The study involves about 220 participants divided into groups: people with inflammatory bowel disease, people with irritable bowel syndrome, people with other digestive disorders, and healthy controls.

AI-generated summary from trial data · Jun 5, 2026 · Not medical advice

Trial locations(3 sites)

United States

Med-Care Research Corp, Miami, Florida

ALPCO, Salem, New Hampshire

Gastro Intestinal Research Institute of Northern Ohio,, Westlake, Ohio