[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100654978":3},{"organization":4,"outcomesModule":7,"designInfo":24,"detailedDescription":27,"studyPopulation":28,"armGroups":29,"interventions":23,"overallOfficials":33,"centralContacts":38,"locations":23,"responsibleParty":44,"collaborators":23,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":23,"eligibilityCriteria":54,"healthyVolunteers":50,"sex":55,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":61,"studyType":62,"phases":23,"briefSummary":63,"conditions":64,"keywords":67,"overallStatus":72,"whyStopped":23,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":78,"leadSponsor":80,"locationsCount":23},{"fullName":5,"class":6},"Assiut University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":23},[9],{"measure":10,"description":11,"timeFrame":12},"Diagnostic performance of fecal calprotectin","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.","Baseline",[14,17,20],{"measure":15,"description":16,"timeFrame":12},"Correlation with endoscopic findings","Correlation between fecal calprotectin concentration (µg\u002Fg) and endoscopic severity scores (Mayo Endoscopic Subscore or SES-CD).",{"measure":18,"description":19,"timeFrame":12},"Correlation with histopathological findings","Correlation between fecal calprotectin concentration (µg\u002Fg) and histopathological grade of mucosal inflammation.",{"measure":21,"description":22,"timeFrame":12},"Optimal cutoff value of fecal calprotectin","Optimal cutoff value of fecal calprotectin for detecting mucosal inflammation derived from ROC curve analysis.",null,{"allocation":23,"interventionModel":23,"interventionModelDescription":23,"primaryPurpose":23,"observationalModel":25,"timePerspective":26,"maskingInfo":23},"CASE_ONLY","CROSS_SECTIONAL","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.\n\nFecal 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.","Children aged 2 to 18 years presenting with chronic or recurrent gastrointestinal symptoms and scheduled for endoscopic evaluation at the Pediatric Gastroenterology and Endoscopy Units, Assiut University Children Hospital.",[30],{"label":31,"type":23,"description":32,"interventionNames":23},"Single group: Children with gastrointestinal symptoms undergoing endoscopy","Children aged 2-18 years with chronic or recurrent gastrointestinal symptoms who will undergo fecal calprotectin measurement and endoscopic evaluation with mucosal biopsy as part of routine diagnostic work-up.",[34],{"name":35,"affiliation":36,"role":37},"Zeinab m Mohieldeen, prof","Pediatric Department, Assiut University Hospitals","STUDY_CHAIR",[39],{"name":40,"role":41,"phone":42,"phoneExt":23,"email":43},"Manar H Mohamed, Resident","CONTACT","+20 12 23691268","Manar.18313532@med.aun.edu.eg",{"type":45,"investigatorFullName":46,"investigatorTitle":47,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"PRINCIPAL_INVESTIGATOR","Manar Helmy Mohamed","Resident Physician department of pediatrics","100654978","fecal-calprotectin-in-pediatric-gastrointestinal-disorders-100654978",false,"NCT07807527","Fecal Calprotectin in Pediatric Gastrointestinal Disorders","Diagnostic Value of Fecal Calprotectin in Gastrointestinal Disorders Versus Its Correlation With Endoscopic and Histopathological Findings","Inclusion Criteria:\n\n* \\- Age 2 to 18 years\n* Chronic gastrointestinal symptoms of more than 4 weeks duration (chronic diarrhea, recurrent abdominal pain, rectal bleeding, unexplained weight loss, or failure to thrive)\n* Scheduled for upper gastrointestinal endoscopy and\u002For ileocolonoscopy with mucosal biopsy\n* Written informed consent from parents or legal guardians\n\nExclusion Criteria:\n\n* Age below 2 years\n* Use of NSAIDs, systemic corticosteroids, or antibiotics within 4 weeks before stool sampling\n* Documented acute gastrointestinal infection, surgical gastrointestinal bleeding, or intestinal parasitic infestation\n* Previous gastrointestinal surgery, known malignancy, chronic liver disease, chronic kidney disease, or cystic fibrosis\n* Refusal of parents or legal guardians to participate\n* Failure to obtain an adequate stool sample","ALL","2 Years","18 Years",{"count":59,"type":60},120,"ESTIMATED","1 Day","OBSERVATIONAL","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.",[65,66],"Gastrointestinal Diseases","Inflammatory Bowel Diseases",[68,69,70,71],"Fecal calprotectin","Pediatric","Endoscopy","Histopathology","NOT_YET_RECRUITING","2026-09-02",{"date":75,"type":76},"2026-09-08","ACTUAL",{"date":73,"type":60},{"date":79,"type":60},"2028-08-01",{"name":5,"class":6}]