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

Completed

Conditions studied: IBD (Inflammatory Bowel Disease), IBS - Irritable Bowel Syndrome, Crohn Disease (CD), UC - Ulcerative Colitis

In brief

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.

Key facts

Study ID: NCT07089420
Run by: American Laboratory Products Company
People needed: 121
Starts: 2025-07-07
Expected to finish: 2026-04-15
Last updated by the study team: 2026-04-28

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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)

You may not qualify if…

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

Where it is running

ALPCO — Salem, New Hampshire, United States

Full record on ClinicalTrials.gov

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