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

Launched by AMERICAN LABORATORY PRODUCTS COMPANY · Jul 21, 2025

Keywords

ClinConnect Summary

This study is looking at the levels of a protein called calprotectin found in stool, which helps show if there is inflammation in the intestines. Doctors use calprotectin tests to help tell the difference between conditions like inflammatory bowel disease (IBD), such as Crohn’s disease or ulcerative colitis, and non-inflammatory conditions like irritable bowel syndrome (IBS). This trial aims to find out what a normal calprotectin level looks like in healthy adults without any intestinal problems.

If you are 22 years or older, don’t have any gut symptoms or a history of bowel diseases, and are willing to collect and send in one stool sample from home using a simple kit, you might be eligible to join. There are no medical procedures involved, and participants will be compensated for their time. This study will help doctors better understand calprotectin test results to improve diagnosis and care for people with digestive conditions.

Gender

ALL

Eligibility criteria

• 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