ALPCO/Calprotectin CLIA Assay: Expected Values of Calprotectin in Healthy Subjects (NCT07089420) | Clinical Trial Compass
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 range
22 Years
Sex
ALL
See this in plain English?
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Establish the Expected Reference Range for Fecal Calprotectin in Healthy Adults