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.
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Yehia M Alaa, Resident
- 전화번호: 01552751879
- 이메일: Yehia.18313599@med.aun.edu.eg
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
Adult patients with ulcerative colitis or Crohn's disease starting or escalating medical therapy at the Gastroenterology and Hepatology Unit, Assiut University.
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: COHORT
- 시간 관점: PROSPECTIVE
코호트 및 개입
그룹/코호트 |
|---|
|
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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Proportion of patients with endoscopic healing
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Proportion of patients with histological healing
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
|
공동 작업자 및 조사자
수사관
- 연구 의자: Mohamed Z Hagez, prof, Internal Medicine Department, Assiut University Hospitals
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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