RecruitingNCT06810518

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

Sponsor

American Laboratory Products Company

Enrollment

220 participants

Start Date

Mar 25, 2025

Study Type

OBSERVATIONAL

Conditions

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

Summary

The ALPCO Calprotectin CLIA is an in vitro diagnostic test intended to quantitatively measure concentrations of fecal calprotectin in human stool samples. Calprotectin is a protein biomarker of mucosal inflammation. Measurement of calprotectin can aid in the diagnosis of Inflammatory Bowel Diseases (IBD), specifically Crohn's Disease (CD) and Ulcerative Colitis (UC), as well as aid in the differentiation of IBD from Irritable Bowel Syndrome (IBS) when used in conjunction with other diagnostic testing and the total clinical picture. The goal of the study is to generate data to support positive and negative predictive value of the ALPCO Calprotectin assay in patients with signs and symptoms of IBS or IBD.

Eligibility

Min Age: 22 Years

Plain Language Summary

Simplified for easier understanding

This study is validating a laboratory test called the ALPCO Calprotectin CLIA Assay, which measures calprotectin — a protein released when there is inflammation in the gut. Elevated calprotectin levels can indicate conditions like Crohn's disease or ulcerative colitis. **You may be eligible if...** - You are providing a stool sample as part of your routine clinical care - You have or are being evaluated for inflammatory bowel disease or gut inflammation - You meet the study's consent and age requirements **You may NOT be eligible if...** - You are unable to provide a stool sample - You have conditions that would interfere with the test results - You do not meet the clinical criteria set by the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEALPCO Calprotectin CLIA

Measurement of calprotectin in feces

Locations(3)

Med-Care Research Corp

Miami, Florida, United States

ALPCO

Salem, New Hampshire, United States

Gastro Intestinal Research Institute of Northern Ohio,

Westlake, Ohio, United States

View Full Details on ClinicalTrials.gov

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NCT06810518

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