Fecal Calprotectin in Pediatric Gastrointestinal Disorders
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age2-18
SponsorAssiut University
About this trial
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
This trial does not accept healthy volunteersQualifiers
- 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
Disqualifiers
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
Trial population
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.
Trial design
Design model
Case-only
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
120 Participants
are grouped into 1 trial groupGroup A: Single group: Children with gastrointestinal symptoms undergoing endoscopy
Trial outcomes
Primary outcomes
1
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.
Time frame
BaselineSecondary outcomes
1
Correlation with endoscopic findings
Correlation between fecal calprotectin concentration (µg/g) and endoscopic severity scores (Mayo Endoscopic Subscore or SES-CD).
Time frame
Baseline2
Correlation with histopathological findings
Correlation between fecal calprotectin concentration (µg/g) and histopathological grade of mucosal inflammation.
Time frame
Baseline3
Optimal cutoff value of fecal calprotectin
Optimal cutoff value of fecal calprotectin for detecting mucosal inflammation derived from ROC curve analysis.
Time frame
BaselineLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: