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NCT07807527
Fecal Calprotectin in Pediatric Gastrointestinal Disorders
Conditions: Gastrointestinal Diseases, Inflammatory Bowel Diseases
Sex: All
Ages: 2 Years – 18 Years
Healthy volunteers: No
Enrollment: 120
Sponsor: Assiut University
Summary
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.
Eligibility Criteria
Inclusion Criteria:
* \- Age 2 to 18 years
* Chronic gastrointestinal symptoms of more than 4 weeks duration (chronic diarrhea, recurrent abdominal pain, rectal bleeding, unexplained weight loss, or failure to thrive)
* Scheduled for upper gastrointestinal endoscopy and/or ileocolonoscopy with mucosal biopsy
* Written informed consent from parents or legal guardians
Exclusion Criteria:
* Age below 2 years
* Use of NSAIDs, systemic corticosteroids, or antibiotics within 4 weeks before stool sampling
* Documented acute gastrointestinal infection, surgical gastrointestinal bleeding, or intestinal parasitic infestation
* Previous gastrointestinal surgery, known malignancy, chronic liver disease, chronic kidney disease, or cystic fibrosis
* Refusal of parents or legal guardians to participate
* Failure to obtain an adequate stool sample
Source: ClinicalTrials.gov (NCT07807527). StuddyBuddy aggregates publicly available trial information.