Urinary PGE-MUM as a Marker for Ulcerative Colitis Activity (PGE-MUM_UC)
Urinary Prostaglandin E-Major Metabolite (PGE-MUM) Discriminates Disease Activity in Ulcerative Colitis: A Cross-Sectional Study From Egypt
Ulcerative colitis (UC) is a chronic inflammatory bowel disease that requires regular monitoring of disease activity. Currently, assessment depends on invasive colonoscopy or clinical scores that may not accurately reflect intestinal inflammation. This study aims to evaluate whether urinary Prostaglandin E-Major Metabolite (PGE-MUM) can serve as a non-invasive biomarker to discriminate disease activity in patients with ulcerative colitis.
This cross-sectional study will be conducted at Al-Rajhi University Hospital, Assiut University, Egypt.This study plans to enroll 114 adult patients (≥18 years) with confirmed UC diagnosis, divided into two equal groups: active disease and remission (57 patients each). Disease activity will be assessed using the Mayo Endoscopic Score (MES) and Clinical Activity Index (CAI). Urine samples will be collected from all participants to measure PGE-MUM levels. Blood samples will be tested for CRP, CBC, albumin, and creatinine. Colonoscopy with biopsy will be performed for endoscopic scoring and histopathological assessment using Geboes score.
The primary outcome is to establish urinary PGE-MUM as a validated discriminatory biomarker for distinguishing active disease from remission in Egyptian patients with UC. Secondary outcomes include comparing PGE-MUM with CRP, determining the optimal cut-off value, and correlating PGE-MUM levels with MES and Geboes score.
If successful, urinary PGE-MUM could provide a simple, non-invasive, and cost-effective method for monitoring UC activity in the Egyptian healthcare setting, reducing the need for frequent colonoscopies and overcoming cultural barriers associated with stool collection.
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Randa Mahrous Roshdy, Master of Internal Medicine
- Numéro de téléphone: +201021584548
- E-mail: randa011188@med.aun.edu.eg
Sauvegarde des contacts de l'étude
- Nom: Ahmed Abd El Fadil Maghraby, MD
- Numéro de téléphone: +201122871357
- E-mail: dr_magraby@aun.edu.eg
Lieux d'étude
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Asyut, Egypte, 71515
- Al-Rajhi University Hospital
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Contact:
- Randa Mahrous Roshdy, MSc
- Numéro de téléphone: +201021584548
- E-mail: randa011188@med.aun.edu.eg
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Sous-enquêteur:
- Randa Mahrous Roshdy, MSc
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Adult patients aged ≥18 years
- Confirmed diagnosis of Ulcerative Colitis based on clinical, endoscopic, and histopathological criteria
- Active disease (Mayo Endoscopic Score 2-3, Clinical Activity Index ≥4) OR remission (Mayo Endoscopic Score 0-1, Clinical Activity Index ≤3)
- Willing and able to provide written informed consent
Exclusion Criteria:
- Patients with other types of colitis (e.g., Crohn's disease, infectious colitis, ischemic colitis)
- History of colectomy
- Current smokers
- Chronic lung disease
- Malignancy
- Use of laxatives or NSAIDs within 2 weeks prior to enrollment
- Chronic kidney disease
- Pregnancy or lactation
- Active infection
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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Active UC Group
Patients with active ulcerative colitis (Mayo Endoscopic Score 2-3, Clinical Activity Index ≥4)
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Remission UC
Patients with ulcerative colitis in remission (Mayo Endoscopic Score 0-1, Clinical Activity Index ≤3)
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Urinary PGE-MUM Levels Discriminates Disease Activity in UC
Délai: At the time of enrollment (single visit, cross-sectional assessment)
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To establish urinary PGE-MUM as a validated discriminatory biomarker for distinguishing active disease from remission in Egyptian patients with ulcerative colitis.Disease activity is assessed using the Mayo Endoscopic Score (MES, 0-3; higher=worse) and Clinical Activity Index (CAI, 0-19; higher=worse).
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At the time of enrollment (single visit, cross-sectional assessment)
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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Correlation between PGE-MUM and CRP
Délai: At enrollment
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To compare urinary PGE-MUM levels with serum C-reactive protein (CRP) levels in patients with active and remission UC. Disease activity is assessed using the Mayo Endoscopic Score (MES, 0-3; higher=worse) and Clinical Activity Index (CAI, 0-19; higher=worse). |
At enrollment
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Optimal PGE-MUM cut-off value for disease activity
Délai: At enrollment
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To determine the optimal cut-off value of urinary PGE-MUM for discriminating active UC from remission using ROC curve analysis. Disease activity is assessed using the Mayo Endoscopic Score (MES, 0-3; higher=worse) and Clinical Activity Index (CAI, 0-19; higher=worse). |
At enrollment
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Correlation between PGE-MUM and Endoscopic/Histologic scores
Délai: At enrollment
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The Mayo Endoscopic Score (MES) ranges from 0 to 3, with higher scores indicating more severe disease.
The Geboes histologic score ranges from 0 to 5.4, with higher scores indicating more severe inflammation.
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At enrollment
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Mohamed Zain El Den Hafez, Professor, Assiut University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- ASU_PhD_UC_2026_001
Plan pour les données individuelles des participants (IPD)
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Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
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