Tests a stool calprotectin assay in people with bowel symptoms
Tests a stool test that measures calprotectin, to help tell inflammatory bowel disease from IBS.
Plain-language title generated from the registry record
Registry title: ALPCO Calprotectin CLIA Assay - Measurement of Calprotectin Levels in Human Stool
Key facts
- Where
- Miami, Salem, and Westlake, United StatesSee the 3 sites
Where in United States
- Med-Care Research CorpMiami, United StatesTaking people
- ALPCOSalem, United StatesNot yet recruiting
- Gastro Intestinal Research Institute of Northern Ohio,Westlake, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- American Laboratory Products Company
- Trial code
- NCT06810518
- Record updated
- 30 October 2026
- Original description
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.Read full original descriptionShow less
ALPCO Calprotectin CLIA Assay - Measurement of Calprotectin Levels in Human Stool
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.
Inclusion: 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: 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; 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; 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); Current or active upper gastrointestinal disease (e.g., esophagitis, gastritis, GERD, or acid reflux) with ongoing symptoms or requiring active treatment; Any condition that in the opinion of the investigator should preclude participation in the study; Unable or unwilling to provide a stool specimen; Samples are not collected according to sampling protocol.