Urinary PGE-MUM as a Marker for Ulcerative Colitis Activity (PGE-MUM_UC)
Urinary Prostaglandin E-Major Metabolite (PGE-MUM) Discriminates Disease Activity in Ulcerative Colitis: A Cross-Sectional Study From Egypt
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.
調査の概要
状態
条件
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前:Randa Mahrous Roshdy, Master of Internal Medicine
- 電話番号:+201021584548
- メール:randa011188@med.aun.edu.eg
研究連絡先のバックアップ
- 名前:Ahmed Abd El Fadil Maghraby, MD
- 電話番号:+201122871357
- メール:dr_magraby@aun.edu.eg
研究場所
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Asyut、エジプト、71515
- Al-Rajhi University Hospital
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コンタクト:
- Randa Mahrous Roshdy, MSc
- 電話番号:+201021584548
- メール:randa011188@med.aun.edu.eg
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副調査官:
- Randa Mahrous Roshdy, MSc
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
コホートと介入
グループ/コホート |
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Active UC Group
Patients with active ulcerative colitis (Mayo Endoscopic Score 2-3, Clinical Activity Index ≥4)
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Remission UC
Patients with ulcerative colitis in remission (Mayo Endoscopic Score 0-1, Clinical Activity Index ≤3)
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Urinary PGE-MUM Levels Discriminates Disease Activity in UC
時間枠:At the time of enrollment (single visit, cross-sectional assessment)
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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).
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At the time of enrollment (single visit, cross-sectional assessment)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Correlation between PGE-MUM and CRP
時間枠:At enrollment
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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). |
At enrollment
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Optimal PGE-MUM cut-off value for disease activity
時間枠:At enrollment
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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). |
At enrollment
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Correlation between PGE-MUM and Endoscopic/Histologic scores
時間枠:At enrollment
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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.
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At enrollment
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協力者と研究者
スポンサー
捜査官
- 主任研究者:Mohamed Zain El Den Hafez, Professor、Assiut University
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- ASU_PhD_UC_2026_001
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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