Effect of Real-world Tight Control Management of Inflammatory Bowel Disease
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Rate of Relapse
研究概览
简要总结
Inflammatory bowel disease, which includes Crohn's disease and ulcerative colitis, is a condition that causes inflammation in the gastrointestinal tract. The disease goes through periods of remission and flare. Biomarkers such as fecal calprotectin have been proposed as a tool to monitor disease activity. Fecal calprotectin is a test that measures the amount of inflammation in the stool. Monitoring fecal calprotectin levels can assist gastroenterologists in making decisions regarding patients' IBD treatment such as whether to increase the dose of medications. A recent study showed that frequent measurement of fecal calprotectin every 3 months, also called the tight-control strategy, was associated with improved clinical outcomes in IBD patients. The purpose of this study is to assess whether the tight-control monitoring strategy, which includes fecal calprotectin monitoring every 3 months, improves clinical outcomes in IBD when performed in the real world compared to routine clinical practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Crohn's disease or ulcerative colitis based on clinical, endoscopic, radiologic or histologic criteria.
- •Followed by a gastroenterologist at Hamilton Health Sciences, St. Joseph's Healthcare Hamilton, and London Health Sciences
- •Aged 18 or older
- •In clinical remission according to the clinical symptom assessment (Partial Mayo score < 2 or Harvey-Bradshaw Index < 4)
- •Currently treated with adalimumab
排除标准
- •Current abdominal abscess
- •Inability or unwillingness to provide informed consent
- •Any other condition, which in the opinion of the investigators would impede competence or compliance or possibly hinder completion of the study
研究组 & 干预措施
Tight control
Group that will receive fecal calprotectin testing every 3 months
干预措施: Fecal calprotectin (Diagnostic Test)
Standard care
Routine clinical care
干预措施: Routine care (Other)
结局指标
主要结局
Rate of Relapse
时间窗: 12 months
This will be a composite outcome of clinical symptom relapse (based on elevation of symptom scores like rise in Harvey Bradshaw Index \>=3 points for Crohn's disease and Partial Mayo score \>=2 points for ulcerative colitis), hospitalization, prednisone use, or IBD-related surgery
次要结局
- Rate of Clinical symptom relapse(12 months)
- Incidence of Hospitalizations(12 months)
- Incidence of change in medical therapies(12 months)