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RECRUITING

ALPCO/Calprotectin CLIA Assay: Expected Values of Calprotectin in Healthy Subjects

NCT07089420 · View on ClinicalTrials.gov ↗

Study Summary

This study is evaluating the levels of calprotectin, a protein found in stool, in healthy adults. Calprotectin is a marker of inflammation in the intestines and can help doctors tell the difference between inflammatory bowel diseases (IBD), like Crohn's disease or ulcerative colitis, and non-inflammatory conditions like irritable bowel syndrome (IBS). In this study, healthy volunteers aged 22 and older will collect a stool sample at home using a simple kit and mail it to the study site. The samples will be tested using a new laboratory method called the ALPCO Calprotectin CLIA assay. The goal is to confirm what level of calprotectin is considered "normal" in people without intestinal disease. Participation involves just one stool sample, and there are no medical procedures. Volunteers will be compensated for their time. The study will help improve how doctors interpret calprotectin test results in clinical settings.

Interventions

  • DEVICE ALPCO Calprotectin CLIA

Study Locations (1)

New Hampshire

  • ALPCO — Salem

Trial Details

FieldValue
Enrollment Target 120 participants
Start Date 2025-07-07
Est. Completion 2026-10

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT07089420

The ClinicalTrials.gov registry entry for NCT07089420 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 120 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 4 conditions, with IBS - Irritable 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: NCT07089420 reports 1 study location spanning 1 distinct geographic area — top geographies include New Hampshire. 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 NCT07089420 about?

NCT07089420 is a clinical study titled "ALPCO/Calprotectin CLIA Assay: Expected Values of Calprotectin in Healthy Subjects". This study is evaluating the levels of calprotectin, a protein found in stool, in healthy adults. Calprotectin is a marker of inflammation in the intestines and can help doctors tell the difference between inflammatory bowel diseases (IBD), like Crohn's disease or ulcerative colitis, and non-inflamm...

What is the current status of trial NCT07089420?

This trial is currently recruiting. The enrollment target is 120 participants. The study started on 2025-07-07. Estimated completion is 2026-10.

What conditions does trial NCT07089420 study?

This clinical trial studies the following conditions: IBS - Irritable Bowel Syndrome, Crohn Disease (CD), IBD (Inflammatory Bowel Disease), UC - 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 NCT07089420?

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 NCT07089420?

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 NCT07089420 being conducted?

This trial has 1 study location across New Hampshire. 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