NCT07089420Completed
ALPCO/Calprotectin CLIA Assay: Expected Values of Calprotectin in Healthy Subjects
Source: ClinicalTrials.gov · Last updated 28 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 121 (actual)
- First submitted
- 21 Jul 2025
- Start date
- 7 Jul 2025
- Primary completion date
- 15 Apr 2026
- Lead sponsor
- American Laboratory Products Company
- Diseases
- Crohn's disease, Ulcerative colitis
- NCT number
- NCT07089420
What you commit to
- Study type: Observational
- Participants enrolled: 121
- From 7 Jul 2025 to the primary completion date, 15 Apr 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Unable or unwilling to provide a stool sample
- Known active intestinal cancer or history of intestinal cancer with abnormal clinical findings
- Currently receiving chemotherapy or systemic immunosuppressive medications
- Use of proton pump inhibitors (PPIs) or H2-receptor antagonists within the last 2 weeks
- Use of NSAIDs (including aspirin) for 7 or more days in the past 2 weeks
- Presence of gastrointestinal symptoms such as abdominal pain, diarrhea, altered appetite, weight loss, or anemia
- Samples collected not following protocol requirements
- Any other condition that, in the opinion of the investigator, may interfere with study participation or data validity
Who the study is looking for
- Adults aged ≥22 years
- No abdominal symptoms and no history of inflammatory bowel disease (IBD), irritable bowel syndrome (IBS), or other chronic intestinal disorders
- May have undergone colonoscopy with negative findings within the past month or never undergone colonoscopy
- Able and willing to provide a stool sample according to the collection protocol
- Able to understand the study and sign the informed consent form (ICF)
Age in the registry: 22 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| ALPCO Coordinator of this site? Confirm its status | Salem | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.