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RECRUITING

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

NCT06810518 · View on ClinicalTrials.gov ↗

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.

Interventions

  • DEVICE ALPCO Calprotectin CLIA

Study Locations (3)

Florida

  • Med-Care Research Corp — Miami

New Hampshire

  • ALPCO — Salem

Ohio

  • Gastro Intestinal Research Institute of Northern Ohio, — Westlake

Trial Details

FieldValue
Enrollment Target 220 participants
Start Date 2025-03-25
Est. Completion 2026-12-31

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06810518

The ClinicalTrials.gov registry entry for NCT06810518 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 220 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is American Laboratory Products Company, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Inflammatory Bowel Syndrome appearing as the primary indexed condition, and to 1 intervention — of which ALPCO Calprotectin CLIA is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06810518 reports 3 study locations spanning 3 distinct geographic areas — top geographies include Florida, New Hampshire, Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06810518 about?

NCT06810518 is a clinical study titled "ALPCO Calprotectin CLIA Assay - Measurement of Calprotectin Levels in Human Stool". 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 ...

What is the current status of trial NCT06810518?

This trial is currently recruiting. The enrollment target is 220 participants. The study started on 2025-03-25. Estimated completion is 2026-12-31.

What conditions does trial NCT06810518 study?

This clinical trial studies the following conditions: Inflammatory Bowel Syndrome, Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis). These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06810518?

The interventions under investigation include: ALPCO Calprotectin CLIA (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06810518?

This trial is sponsored by American Laboratory Products Company, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06810518 being conducted?

This trial has 3 study locations across Florida, New Hampshire, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial