💬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.
📋 Eligibility rules (as published)
Inclusion criteria:
* Male or female, ≥22 years of age (adults)
* Subjects with suspected inflammatory bowel disease or irritable bowel syndrome presenting one or more of the following symptoms: abdominal pain, diarrhea, altered appetite, anemia, or unexpected weight loss. Not all symptoms are required; clinical presentation must support suspicion of inflammatory bowel disease or irritable bowel syndrome in the investigator's opinion.
* Able to provide a sample either within 14 days before beginning bowel preparation for the scheduled colonoscopy, or between 3 and 14 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)
* Subjects receiving chemotherapy or systemic immunosuppressive drugs without completing an 8-week washout period IBD patients who have previously diagnosed with 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 surgical resection or diversion procedure.
* Current or active upper gastrointestinal disease (e.g., esophagitis, gastritis, GERD, or acid reflux) with ongoing symptoms or requiring active treatment.
* Use of proton pump inhibitors (PPIs) or H2-receptor antagonists within the 2 weeks prior to providing the stool sample.
* Use of NSAIDs, including aspirin, on seven or more days within the 14 days prior to sample collection.
* Samples are not collected according to sampling protocol.
* Any condition that in the opinion of the investigator should preclude participation in the study.
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