Urinary PGE-MUM as a Marker for Ulcerative Colitis Activity

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssiut University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Patients with other types of colitis (e.g., Crohn's disease, infectious colitis, ischemic colitis)

History of colectomy

Current smokers

Chronic lung disease

Trial population

Adult Egyptian patients with confirmed diagnosis of Ulcerative Colitis attending the Gastroenterology Clinic at Al-Rajhi University Hospital, Assiut University.

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

114 Participants
are grouped into 2 trial groups
Group A: Active UC Group
Group B: Remission UC

Trial outcomes

Primary outcomes

1

Urinary PGE-MUM Levels Discriminates Disease Activity in UC

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).

Time frame
At the time of enrollment (single visit, cross-sectional assessment)

Secondary outcomes

1

Correlation between PGE-MUM and CRP

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).

Time frame
At enrollment
2

Optimal PGE-MUM cut-off value for disease activity

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).

Time frame
At enrollment
3

Correlation between PGE-MUM and Endoscopic/Histologic scores

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.

Time frame
At enrollment

Other outcomes

Sponsors and contacts

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