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ALPCO Calprotectin CLIA Assay - Measurement of Calprotectin Levels in Human Stool

Recruitingn/aAges 22 Years - anyAllAmerican Laboratory Products Company
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion criteria: * Male or female, โ‰ฅ22 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 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.
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What it tests

  • ALPCO Calprotectin CLIA
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Where

3 sites
Med-Care Research Corp
Miami, United States
ALPCO
Salem, United States
Gastro Intestinal Research Institute of Northern Ohio,
Westlake, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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