Inflammatory Bowel Disease in South Eastern Norway (IBSEN III). Clinical Epidemiology, Diagnostic and Prognostic Factors in Inflammatory Bowel Disease.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,286
- 试验地点
- 1
- 主要终点
- Evidence for ulcerative colitis, Crohn's disease or indeterminate colitis based on specific clinical, endoscopic, histological and radiological criteria
研究概览
简要总结
The IBSEN III study will investigate the incidence of inflammatory bowel disease in South Eastern Norway and describe the clinical course of the disease. The investigators will map newly diagnosed and treatment naive IBD patients at various levels (epidemiological, clinical, psychosocial and nutritional as well as immunological, genetic, epigenetic and microbial) as a basis to improve targeted and individualized treatment and care. The investigators will include incident IBD patients at all local- and university hospitals in the South Eastern Health Region in 2016-2018 and follow-up prospectively for five years. The investigators will use standardized and validated registration methods allowing comparability with previous national and international IBD cohorts, link data to national health registries and collect blood, feces and biopsies for bio banking.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 100 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ulcerative colitis:
- •Diagnostic criteria (at least three out of four criteria present):
- •A history of diarrhea and/or pus in stools for more than 4weeks or repeated episodes.
- •Macroscopic appearance at endoscopy of continuous mucosal inflammation affecting the rectum in continuity with some or the entire colon.
- •Microscopic features on biopsy compatible with UC,
- •No suspicion of CD on small bowel X-ray, ileocolonoscopy or biopsy.
- •Crohn's disease:
- •Diagnostic criteria (at least two of four criteria present):
- •History of abdominal pain, weight loss and/or diarrhea for more than three months.
- •Characteristic endoscopic findings of ulceration (aphthous lesions, snail track ulceration) or cobble stoning or radiological features of stricture or cobble stoning.
- •Histopathology consistent with Crohn's disease (epitheloid granuloma of Langerhans type or transmural discontinuous focal or patchy inflammation).
- •Fistula and/or abscess in relation to affected bowel segments.
- •Inflammatory bowel disease, type unclassified (IBDU) :
- •Patients with evidence on clinical and endoscopic grounds for chronic inflammatory bowel disease affecting the colon, without small bowel involvement, and no definitive histological or other evidence to favor either CD or UC.
- •Pediatric patients:
- •Will be diagnosed according to the Porto-criteria and defined as:
- •Pediatric onset IBD ≤ 16 years Early Onset IBD (EOIBD) < 10 years Very Early Onset IBD (VEOIBD) < 6 years Infantile (and toddler) IBD < 2 years Neonatal IBD < 28 days
- •Exclusion criteria:
- •Other causes of acute or chronic bowel inflammation must be excluded, i.e. infectious colitis, radiation colitis, diversion colitis, solitary rectal ulcer syndrome, graft versus host disease, diverticular colitis, medication associated colitis, ischemic colitis, microscopic colitis, enema associated colitis.
- •Refusal or not able to give informed consent
排除标准
- 未提供
结局指标
主要结局
Evidence for ulcerative colitis, Crohn's disease or indeterminate colitis based on specific clinical, endoscopic, histological and radiological criteria
时间窗: At baseline
Diagnosis according to the Lennard Jones Criteria for the diagnosis of inflammatory bowel disease
次要结局
- Change in IBD diagnosis between baseline and one year follow-up(1 year (+/-3 months))
- Change in IBD diagnosis between one year and five year follow-up(5 year (+/-3 months))
- Change in disease classification (montreal Classification) between baseline and one year follow-up.(1 year (+/-3 months))
- Change in disease classification (montreal Classification) between one and five year follow-up(5 year (+/-3 months))
- IBD related bowel surgery(5 year (+/-3 months))
研究者
Marte Lie Høivik
MD Postdoc PhD
Oslo University Hospital