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NCT ID: NCT02197780 Completed - Ulcerative Colitis Clinical Trials

Head-to-head Comparison of Two Fecal Biomarkers to Screen Children for IBD

CACATU
Start date: September 2014
Phase: N/A
Study type: Observational [Patient Registry]

RATIONALE: A substantial proportion of children and teenagers with suspected inflammatory bowel disease (IBD) referred for endoscopy do not have the disease. The investigators designed a clinical decision rule that included a calprotectin stool test to discern which patients require further investigations. The accuracy of this diagnostic strategy is 88.5% with a low risk of missing IBD cases. Although the number of negative endoscopies was reduced after introduction of this strategy, still 22% of the referred children and teenagers underwent an unnecessary invasive test. S100A12 (calgranulin C) is a cytoplasmic protein secreted exclusively by activated neutrophils and this stool marker may be more IBD-specific than calprotectin. OBJECTIVE: To determine whether the specificity of S100A12 is superior to the specificity of calprotectin without sacrificing sensitivity HYPOTHESIS: Inclusion of the calgranulin C stool test will improve the specificity of the screening-strategy.