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Clinical Trials in the USA / NCT06810518
Recruiting Observational

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

NCT06810518 · tracked via the Priya Life Science USA tracker
Sponsor
American Laboratory Products Company
Phase
Observational
Started
2025-03-25
Last updated
2026-04-28

Condition(s) studied

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

Investigational drug(s) / intervention(s)

ALPCO Calprotectin CLIA

ALPCO Calprotectin CLIA: Measurement of calprotectin in feces

Study 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

Sex
ALL
Min age
22 Years
Max age
Healthy volunteers
Accepted
Inclusion criteria: * 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 criteria: * 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. Using an IRB approved consent form, all study participants will be advised of study requirements and potential risks associated with study participation.

Primary outcome measure(s)

Trial sites (3)

FacilityCityRegionStatus
Med-Care Research Corp Miami Florida Recruiting
ALPCO Salem New Hampshire Not Yet Recruiting
Gastro Intestinal Research Institute of Northern Ohio, Westlake Ohio Recruiting

More American Laboratory Products Company trials in the USA

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06810518 on ClinicalTrials.gov ↗ ← All trials in the USA