ALPCO Calprotectin CLIA Assay - Measurement of Calprotectin Levels in Human Stool
Recruiting now
Conditions studied: Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis), Inflammatory Bowel Syndrome
In brief
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.
Key facts
- Study ID
- NCT06810518
- Run by
- American Laboratory Products Company
- People needed
- 220
- Starts
- 2025-03-25
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2026-04-28
Who can join
Age: 22 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 sampling protocol.
- Any condition that in the opinion of the investigator should preclude participation in the study.
- Using an IRB approved consent form, all study participants will be advised of study requirements and potential risks associated with study participation.
Where it is running
- Med-Care Research Corp — Miami, Florida, United States (enrolling)
- Gastro Intestinal Research Institute of Northern Ohio, — Westlake, Ohio, United States (enrolling)
- ALPCO — Salem, New Hampshire, United States
Full record on ClinicalTrials.gov
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