Ulcerative Colitis (UC)
Conditions
Keywords
Ulcerative Colitis, PGE-MUM, Urinary biomarker, Inflammatory Bowel Disease, Non-invasive biomarker
Brief summary
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.
Interventions
None listed
Sponsors
Assiut University
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Urinary PGE-MUM Levels Discriminates Disease Activity in UC | At the time of enrollment (single visit, cross-sectional assessment) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation between PGE-MUM and CRP | At enrollment | 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). |
| Optimal PGE-MUM cut-off value for disease activity | At enrollment | 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). |
| Correlation between PGE-MUM and Endoscopic/Histologic scores | At enrollment | 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. |
Countries
Egypt
Contacts
CONTACTRanda Mahrous Roshdy, Master of Internal Medicine
CONTACTAhmed Abd El Fadil Maghraby, MD
PRINCIPAL_INVESTIGATORMohamed Zain El Den Hafez, Professor
Assiut University
Outcome results
None listed