Al-Rajhi University Hospital
Asyut, 71515, Egypt
Location contact
Randa Mahrous Roshdy, MSc
CONTACT
Randa Mahrous Roshdy, MSc
SUB_INVESTIGATOR
NCT Number: NCT07637045
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
Asyut, 71515, Egypt
Randa Mahrous Roshdy, MSc
CONTACT
Randa Mahrous Roshdy, MSc
SUB_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Ahmed Abd El Fadil Maghraby, MD
CONTACT
Randa Mahrous Roshdy, Master of Internal Medicine
CONTACT
Assiut University
Other
Urinary Prostaglandin E-Major Metabolite (PGE-MUM) Discriminates Disease Activity in Ulcerative Colitis: A Cross-Sectional Study From Egypt
Acronym: PGE-MUM_UC
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