NCT07637045Not yet recruiting
Urinary PGE-MUM as a Marker for Ulcerative Colitis Activity
Urinary Prostaglandin E-Major Metabolite (PGE-MUM) Discriminates Disease Activity in Ulcerative Colitis: A Cross-Sectional Study From Egypt
Source: ClinicalTrials.gov · Last updated 11 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 114 (estimated)
- First submitted
- 4 Jun 2026
- Start date
- Aug 2026
- Primary completion date
- Jan 2027
- Lead sponsor
- Assiut University
- Diseases
- Ulcerative colitis
- NCT number
- NCT07637045
What you commit to
- Study type: Observational
- Planned participants: 114
- From Aug 2026 to the primary completion date, Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of laxatives or NSAIDs within 2 weeks prior to enrollment
Other illness
- Patients with other types of colitis (e.g., Crohn's disease, infectious colitis, ischemic colitis)
- History of colectomy
- Chronic lung disease
- Malignancy
- Chronic kidney disease
- Active infection
Other
- Current smokers
- Pregnancy or lactation
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Al-Rajhi University Hospital Coordinator of this site? Confirm its status | Asyut | Egypt | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.