Early Changes in Inflammatory Indices and Healing in IBD
Early Kinetic Changes in Blood-Based Inflammatory Indices as Predictors of Endoscopic and Histological Healing in Patients With Inflammatory Bowel Disease
This prospective observational study aims to evaluate early changes in blood-based inflammatory indices during the first 4 weeks after treatment initiation or escalation and their relation to endoscopic and histological healing at 12 to 16 weeks in adult patients with inflammatory bowel disease.
調査の概要
詳細な説明
Objective assessment of treatment response is important in inflammatory bowel disease. This prospective cohort study will include adult patients with ulcerative colitis or Crohn's disease who are starting or escalating medical therapy.
Blood-based inflammatory indices will be assessed at baseline and at 4 weeks. Endoscopic and histological outcomes will be evaluated at approximately 12 to 16 weeks.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Yehia M Alaa, Resident
- 電話番号：01552751879
- メール：Yehia.18313599@med.aun.edu.eg
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
Adult patients with ulcerative colitis or Crohn's disease starting or escalating medical therapy at the Gastroenterology and Hepatology Unit, Assiut University.
説明
Inclusion Criteria:
- Age 18 years or older
- Confirmed diagnosis of ulcerative colitis or Crohn's disease
- Objective evidence of active disease at baseline
- Planned initiation or escalation of IBD treatment
- Baseline CBC with differential, CRP, and serum albumin available
- Planned follow-up assessment at approximately 12-16 weeks
- Planned follow-up colonoscopy with mucosal biopsies at approximately 12-16 weeks
- Written informed consent
Exclusion Criteria:
- Active infection
- Recent major surgery
- Malignancy
- Hematological malignancy or disorder substantially altering leukocyte or platelet counts
- Significant uncontrolled liver disease
- Severe renal disease expected to substantially affect inflammatory markers
- Recent blood transfusion
- Pregnancy
- Concomitant autoimmune inflammatory disease
- Systemic corticosteroids used for another indication
- Acute severe infection around the time of blood sampling
- Inadequate follow-up or missing essential data
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
- 観測モデル：COHORT
- 時間の展望：PROSPECTIVE
コホートと介入
グループ/コホート |
|---|
|
Single cohort: Adult IBD Patients
Adult patients with ulcerative colitis or Crohn's disease who are starting or escalating medical therapy and will be followed for early changes in inflammatory indices and later endoscopic and histological outcomes. |
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 |
|---|---|---|
|
Proportion of patients with endoscopic healing
時間枠：12 to 16 weeks
|
Proportion of patients achieving endoscopic healing at follow-up, defined as Mayo Endoscopic Score = 0 in ulcerative colitis or SES-CD < 3 in Crohn's disease. |
12 to 16 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Proportion of patients with histological healing
時間枠：12 to 16 weeks
|
Proportion of patients achieving histological healing based on histopathological assessment of mucosal biopsies. |
12 to 16 weeks
|
|
Mean change in neutrophil-to-lymphocyte ratio
時間枠：Baseline and at 4 weeks
|
Mean change in neutrophil-to-lymphocyte ratio (NLR) from baseline to 4 weeks. |
Baseline and at 4 weeks
|
|
Mean change in C-reactive protein
時間枠：Baseline and at 4 weeks
|
Mean change in C-reactive protein (CRP) level from baseline to 4 weeks. |
Baseline and at 4 weeks
|
|
Mean change in CRP-to-albumin ratio
時間枠：Baseline and at 4 weeks
|
Mean change in CRP-to-albumin ratio (CAR) from baseline to 4 weeks. |
Baseline and at 4 weeks
|
|
Mean change in systemic immune-inflammation index
時間枠：Baseline and at 4 weeks
|
Mean change in systemic immune-inflammation index (SII) from baseline to 4 weeks. |
Baseline and at 4 weeks
|
|
Mean Mayo Endoscopic Score
時間枠：12 to 16 weeks
|
Mean Mayo Endoscopic Score in patients with ulcerative colitis (range 0-3, higher scores indicate more severe endoscopic activity). |
12 to 16 weeks
|
|
Mean SES-CD score
時間枠：12 to 16 weeks
|
Mean Simple Endoscopic Score for Crohn's Disease (SES-CD) (higher scores indicate more severe endoscopic activity). |
12 to 16 weeks
|
協力者と研究者
スポンサー
捜査官
- スタディチェア：Mohamed Z Hagez, prof、Internal Medicine Department, Assiut University Hospitals
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。