ALPCO Calprotectin CLIA Assay - Measurement of Calprotectin Levels in Human Stool (NCT06810518) | Clinical Trial Compass
RecruitingNot Applicable
ALPCO Calprotectin CLIA Assay - Measurement of Calprotectin Levels in Human Stool
United States220 participantsStarted 2025-03-25
Plain-language summary
The ALPCO Calprotectin CLIA is an in vitro diagnostic test intended to quantitatively measure concentrations of fecal calprotectin in human stool samples. Calprotectin is a protein biomarker of mucosal inflammation. Measurement of calprotectin can aid in the diagnosis of Inflammatory Bowel Diseases (IBD), specifically Crohn's Disease (CD) and Ulcerative Colitis (UC), as well as aid in the differentiation of IBD from Irritable Bowel Syndrome (IBS) when used in conjunction with other diagnostic testing and the total clinical picture. The goal of the study is to generate data to support positive and negative predictive value of the ALPCO Calprotectin assay in patients with signs and symptoms of IBS or IBD.
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:
* Male or female, ≥22 years of age (adults)
* Suspected inflammatory bowel disease or irritable bowel syndrome with symptoms such as abdominal pain, diarrhea, altered appetite, weight loss, or anemia
* Able to provide a sample according to the sampling protocol within 72-24 hours prior to the scheduled diagnostic endoscopy or 3-30 days after the colonoscopy.
* Able to understand the study and the tasks required and sign the ICF
Exclusion criteria:
* Unable or unwilling to provide a stool specimen
* Known active intestinal cancer or in remission with abnormal levels (per physician assessment)
* Known active intestinal infection or history of treated intestinal infection with persistent abnormal levels (per physician assessment)
* IBD patients receiving chemotherapy or systemic immunosuppressive drugs without completing an 8-week washout period
* IBD patients who have previously diagnosed IBD managed with immunomodulators, 5-ASA or biologic therapies without completing an 8-week washout period for biologics and immunomodulators or 4 weeks for 5-ASA
* IBD patients who have previously been diagnosed with IBD and have undergone a surgical resection or diversion procedure.
* Known upper Gl disease such as esophagitis or gastritis that might influence the study test's ability to detect intestinal inflammatory disease
* Have taken NSAIDS (including aspirin) on 7 or more days during the 2 weeks before providing the sample
* Samples are not collected according to…
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
In vitro diagnostic value of Calprotectin
Timeframe: Through study completion, up to 52 weeks.