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NCT Number: NCT07807527

Fecal Calprotectin in Pediatric Gastrointestinal Disorders

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.

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Key information

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Diagnostic performance of fecal calprotectin

    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.

Secondary outcomes

  1. Correlation with endoscopic findings

    Time frame: Baseline

    Correlation between fecal calprotectin concentration (µg/g) and endoscopic severity scores (Mayo Endoscopic Subscore or SES-CD).

  2. Correlation with histopathological findings

    Time frame: Baseline

    Correlation between fecal calprotectin concentration (µg/g) and histopathological grade of mucosal inflammation.

  3. Optimal cutoff value of fecal calprotectin

    Time frame: Baseline

    Optimal cutoff value of fecal calprotectin for detecting mucosal inflammation derived from ROC curve analysis.

Study contacts

Contact information is provided by the study sponsor or research team.

Manar H Mohamed, Resident

CONTACT

[email protected]

+20 12 23691268

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Sep 8, 2026
Registry last updated
Sep 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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