Cure8 trial brief
Calprotectin testing is a noninvasive biomarker used to detect gut inflammation. Validating a new automated calprotectin assay could affect how clinicians screen patients with bowel symptoms and decide who needs colonoscopy.
Adults with suspected IBD or IBS, clinicians who order fecal calprotectin testing, and researchers interested in biomarker validation and diagnostic tools for IBD.
This ClinicalTrials.gov record describes a recruiting observational study testing the ALPCO Calprotectin CLIA, an in vitro diagnostic assay that measures fecal calprotectin to help identify intestinal inflammation.
The study will compare assay results (using proposed cut-offs such as 50 µg/g) to gastroenterologist diagnoses based on colonoscopy and histology to estimate sensitivity, specificity, and predictive values for distinguishing IBD (Crohn's disease or ulcerative colitis) from IBS and other disorders.
Study procedures include stool collection before or shortly after colonoscopy (if no treatment started), frozen sample storage, and centralized testing at multiple analytical sites. Planned enrollment targets include patients with confirmed IBD, patients with IBS, patients with other GI disorders, and healthy controls.
The record is a trial-registration (recruiting, observational) describing the study design and goals; it does not report study results or clinical recommendations. Final assay cut-offs and diagnostic performance will depend on completed analytical and clinical validation.
This is a trial registry entry describing planned and ongoing work (recruiting observational study). It reports study design and intended analyses, not findings. Final clinical performance will depend on study results and regulatory review.
Review the original publication for the complete reporting, methods, and context.
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
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