RecruitingNCT07089420

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

Sponsor

American Laboratory Products Company

Enrollment

120 participants

Start Date

Jul 7, 2025

Study Type

OBSERVATIONAL

Conditions

IBD (Inflammatory Bowel Disease)Crohn Disease (CD)IBS - Irritable Bowel Syndrome UC - Ulcerative Colitis

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.

Eligibility

Min Age: 22 Years

Plain Language Summary

Simplified for easier understanding

This study establishes what normal calprotectin levels look like in healthy people using a new laboratory test (CLIA assay). Calprotectin is a protein measured in stool that can indicate gut inflammation. This study focuses only on healthy volunteers without gut disease. **You may be eligible if...** - You are 22 years or older - You have no abdominal symptoms - You have no history of inflammatory bowel disease, irritable bowel syndrome, or other chronic gut disorders - You may have had a normal colonoscopy recently, or never had one **You may NOT be eligible if...** - You have a history of IBD, IBS, or other chronic intestinal conditions - You currently have abdominal symptoms (pain, bloating, diarrhea, etc.) - You are under 22 years old Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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