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NCT06810518 · ClinicalTrials.gov registry record

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

A clinical trial of Inflammatory Bowel Syndrome and Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis), sponsored by American Laboratory Products Company.

Recruiting
Registry status
220
Enrollment target
3
Study locations

NCT06810518: Recruiting study of Inflammatory Bowel Syndrome and Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis), sponsored by American Laboratory Products Company.

NCT06810518 is a study of Inflammatory Bowel Syndrome and Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis) that is actively recruiting participants, run by American Laboratory Products Company. The registered enrollment target is 220 participants. The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06810518, a study of Inflammatory Bowel Syndrome and Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis), is actively recruiting participants, sponsored by American Laboratory Products Company.

RECRUITING
Registry status
220 participants
Enrollment target
3
Study locations

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.

Primary Outcome

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

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

What NCT06810518 shows while recruiting

NCT06810518 is an observational study that tracks outcomes without assigning an intervention. The registered 220 participants enrollment target is mid-sized for trials with a published cap.

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.

NCT06810518 reports a single indexed study location in Florida, New Hampshire, Ohio.

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).

What interventions are being tested in trial NCT06810518?

The interventions under investigation include: ALPCO Calprotectin CLIA (DEVICE).

Who is sponsoring clinical trial NCT06810518?

This trial is sponsored by American Laboratory Products Company, which has 4 total clinical trials registered on ClinicalTrials.gov.

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.

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Source: ClinicalTrials.gov NCT06810518, the US trial registry maintained by the National Library of Medicine. NCT06810518 (mid enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.