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NCT07089420 · ClinicalTrials.gov registry record
ALPCO/Calprotectin CLIA Assay: Expected Values of Calprotectin in Healthy Subjects
A clinical trial of IBS - Irritable Bowel Syndrome and Crohn Disease (CD), sponsored by American Laboratory Products Company.
- Recruiting
- Registry status
- 120
- Enrollment target
- 1
- Study location
NCT07089420: Recruiting study of IBS - Irritable Bowel Syndrome and Crohn Disease (CD), sponsored by American Laboratory Products Company.
NCT07089420 is a study of IBS - Irritable Bowel Syndrome and Crohn Disease (CD) that is actively recruiting participants, run by American Laboratory Products Company. The registered enrollment target is 120 participants, above the 63-participant average among 6 other IBS - Irritable Bowel Syndrome trials with a reported enrollment target (90% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07089420, a study of IBS - Irritable Bowel Syndrome and Crohn Disease (CD), is actively recruiting participants, sponsored by American Laboratory Products Company.
- RECRUITING
- Registry status
- 120 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
Determine the distribution and expected (normal) reference range of fecal calprotectin concentrations in healthy adults using the ALPCO Calprotectin CLIA assay. The outcome will confirm whether the predefined clinical cut-off value of \<50 µg/g accurately reflects a non-inflammatory baseline in an asymptomatic population.
Conditions Studied
Interventions
- DEVICE ALPCO Calprotectin CLIA
Study Locations (1)
New Hampshire
- ALPCO - Salem
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2025-07-07 |
| Est. Completion | 2026-10 |
What NCT07089420 shows while recruiting
NCT07089420 is an observational study that tracks outcomes without assigning an intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, above the 63-participant average among 6 other IBS - Irritable Bowel Syndrome trials with a reported enrollment target (90% higher).
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.
NCT07089420 reports a single indexed study location in New Hampshire.
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.
What interventions are being tested in trial NCT07089420?
The interventions under investigation include: ALPCO Calprotectin CLIA (DEVICE).
Who is sponsoring clinical trial NCT07089420?
This trial is sponsored by American Laboratory Products Company, which has 4 total clinical trials registered on ClinicalTrials.gov.
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.
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