Fecal Calprotectin in Pediatric Gastrointestinal Disorders

Diagnostic Value of Fecal Calprotectin in Gastrointestinal Disorders Versus Its Correlation With Endoscopic and Histopathological Findings

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07807527

Enrollment

120

Registered

2026-09-08

Start date

2026-09-02

Completion date

2028-08-01

Last updated

2026-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrointestinal Diseases, Inflammatory Bowel Diseases

Keywords

Fecal calprotectin, Pediatric, Endoscopy, Histopathology

Brief 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.

Detailed description

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

2 Years to 18 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Diagnostic performance of fecal calprotectin	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.

Secondary

Measure	Time frame	Description
Correlation with endoscopic findings	Baseline	Correlation between fecal calprotectin concentration (µg/g) and endoscopic severity scores (Mayo Endoscopic Subscore or SES-CD).
Correlation with histopathological findings	Baseline	Correlation between fecal calprotectin concentration (µg/g) and histopathological grade of mucosal inflammation.
Optimal cutoff value of fecal calprotectin	Baseline	Optimal cutoff value of fecal calprotectin for detecting mucosal inflammation derived from ROC curve analysis.

Contacts

CONTACTManar H Mohamed, Resident

Manar.18313532@med.aun.edu.eg+20 12 23691268

STUDY_CHAIRZeinab m Mohieldeen, prof

Pediatric Department, Assiut University Hospitals

Outcome results