Study of a Monoclonal Antibody KHK4083 in Moderate Ulcerative Colitis
NCT02647866
Abdominal Pain, Autoimmune Disease
Greenville, South Carolina, United States
View Trial DetailsNCT Number: NCT07807527
This prospective cross-sectional study aims to evaluate the diagnostic value of fecal calprotectin as a non-invasive biomarker in children with gastrointestinal disorders and to assess its correlation with endoscopic and histopathological findings at Assiut University Children Hospital.
Trial opening soon.
Get Notified2 year–18 year
All sexes
Observational
Gastrointestinal symptoms such as chronic abdominal pain, persistent diarrhea, and rectal bleeding are common reasons for referral to pediatric gastroenterology clinics. Distinguishing organic inflammatory disease from functional disorders remains a diagnostic challenge.
Fecal calprotectin is a non-invasive marker of intestinal inflammation. This study will include children aged 2 to 18 years with chronic or recurrent gastrointestinal symptoms who are scheduled for endoscopic evaluation. Fecal calprotectin levels will be measured and compared with endoscopic and histopathological findings to determine diagnostic performance, including sensitivity, specificity, and optimal cutoff values.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Baseline
Sensitivity, specificity, positive predictive value, negative predictive value, and area under the receiver operating characteristic (ROC) curve of fecal calprotectin for detecting mucosal inflammation, using endoscopic and histopathological findings as the reference standard.
Time frame: Baseline
Correlation between fecal calprotectin concentration (µg/g) and endoscopic severity scores (Mayo Endoscopic Subscore or SES-CD).
Time frame: Baseline
Correlation between fecal calprotectin concentration (µg/g) and histopathological grade of mucosal inflammation.
Time frame: Baseline
Optimal cutoff value of fecal calprotectin for detecting mucosal inflammation derived from ROC curve analysis.
Contact information is provided by the study sponsor or research team.
Assiut University
Other
Diagnostic Value of Fecal Calprotectin in Gastrointestinal Disorders Versus Its Correlation With Endoscopic and Histopathological Findings
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