CompletedNot Applicable

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

United States121 participantsStarted 2025-07-07

Plain-language 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.

Who can participate

Age range22 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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) Exclusion Criteria: * 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

What they're measuring

Establish the Expected Reference Range for Fecal Calprotectin in Healthy Adults

Timeframe: Within 2 months of sample collection

Trial details

NCT IDNCT07089420

SponsorAmerican Laboratory Products Company

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-04-15