NCT06810518 ALPCO Calprotectin CLIA Assay - Measurement of Calprotectin Levels in Human Stool
| NCT ID | NCT06810518 |
| Status | Recruiting |
| Phase | — |
| Sponsor | American Laboratory Products Company |
| Condition | Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis) |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2025-03-25 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2025-03-25 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06810518 clinical trial?
This trial is open to participants of all sexes, aged 22 Years or older, studying Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06810518 currently recruiting?
Yes, NCT06810518 is actively recruiting participants. Contact the research team at clinops@alpco.com for enrollment information.
Where is the NCT06810518 trial being conducted?
This trial is being conducted at Miami, United States, Salem, United States, Westlake, United States.
Who is sponsoring the NCT06810518 clinical trial?
NCT06810518 is sponsored by American Laboratory Products Company. The trial plans to enroll 1,000 participants.
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