Efficacy of Exclusive Enteral Nutrition in Adult Active Crohn's Disease With Complications or Failure of Medical Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 主要终点
- Clinical remission after 12 weeks EEN
研究概览
简要总结
Patients with Crohn's disease (CD) could develop complications such as stricture, intestinal fistula and abdominal abscess. Some CD patients had poor response to medical therapy. The efficacy of exclusive enteral nutrition (EEN) to these adult active CD patients is still unclear. The investigators aim to study the efficacy of EEN in induction of remission in adult active CD patients with complications or poor response to drugs.
详细描述
Active CD patients following up in our center who had been diagnosed as complicated disease with stricture, intestinal fistula, abdominal abscess and no response to drugs, were recruited since July 2013. Patients were only offered EEN for 12 weeks without using other drugs except that patients with abscess could use antibiotic therapy with or without percutaneous drainage. The disease activity was assessed by the Crohn's disease activity index (CDAI). CDAI<150 was taken as achieving clinical remission. Demographics and clinical variables were recorded. Nutritional (body mass index, albumin) and inflammatory (High sensitivity C-reactive protein and platelet) index were evaluated at baseline, week 4 and week 12. Some patients performed colonoscopy and/or computed tomography enterography (CTE) /resonance enterography(MRE) before and after EEN. Mucosal healing was assessed under endoscopy with SES-CD and the size of abscess was detected by CTE /MRE.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>18 years old
- •Patients with CD was diagnosed clinically according to previously established international criteria [9]
- •The diagnosis of stricture, fistula and abdominal abscess was confirmed by ultrasound, CT enterography (CTE), and endoscopy. The bowel stricture should mainly cause by inflammation. Intolerance or failure to steroids or IFX was judged by medical history
- •The disease was in an active period.
排除标准
- •Intolerant to EEN or need emergency surgery
- •The bowel stricture should mainly cause by fibrosis
结局指标
主要结局
Clinical remission after 12 weeks EEN
时间窗: July 2013 to October 2015
The Crohn's disease activity index (CDAI)\<150 was taken as achieving clinical remission.
Mucosal healing after EEN
时间窗: July 2013 to October 2015
Mucosal healing was assessed under endoscopy with SES-CD.
次要结局
- The high sensitivity C-reactive protein (mg/L) -Inflammatory parameter assessment(baseline, week 4 and week 12)
- The body mass nutritional parameter assessment(baseline, week 4 and week 12)
- Inflammatory parameter assessment(baseline, week 4 and week 12)
- The albumin (g/L)- nutritional parameter assessment(baseline, week 4 and week 12)
研究者
Xiang Peng
Attending physician
Sixth Affiliated Hospital, Sun Yat-sen University