Urinary Prostaglandin E-Major Metabolite (PGE-MUM) Discriminates Disease Activity in Ulcerative Colitis: A Cross-Sectional Study From Egypt
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Assiut University
- Enrollment
- 114
- Locations
- 1
- Primary Endpoint
- Urinary PGE-MUM Levels Discriminates Disease Activity in UC
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Active UC Group
Patients with active ulcerative colitis (Mayo Endoscopic Score 2-3, Clinical Activity Index ≥4)
Remission UC
Patients with ulcerative colitis in remission (Mayo Endoscopic Score 0-1, Clinical Activity Index ≤3)
Outcomes
Primary Outcomes
Urinary PGE-MUM Levels Discriminates Disease Activity in UC
Time Frame: 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 Outcomes
- Correlation between PGE-MUM and CRP(At enrollment)
- Optimal PGE-MUM cut-off value for disease activity(At enrollment)
- Correlation between PGE-MUM and Endoscopic/Histologic scores(At enrollment)
Investigators
Randa Mahrous Roshdy
PhD Student in Internal Medicine
Assiut University