A Randomized, Controlled, Open-label Study to Assess the the Efficacy of Enteral Nutrition in Fill of the Treatment Blank Period of the Postoperative Maintain Remission Medication for Crohn's Disease (CD).
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The change of patients'CDAI.
研究概览
简要总结
Crohn's disease(CD) is a agnogenic disease which has a lifelong relapse tendency even after surgery treatment.So maintain remission medications were routinely given to patients after surgery.But maintain remission medications,as azathioprine,6-MP, ciclosporin,tripterygium glycosides, had a onset time.The therapeutic effect may appear 3 months~6months after taken medicine.There is a treatment blank period between surgery and onset time of maintain remission medications.Enteral nutrition has been used in the induction remission and maintain remission for CD.May be it can fill the treatment blank period.
详细描述
Crohn's disease(CD) is a agnogenic disease which has a lifelong relapse tendency even after surgery treatment.So maintain remission medications were routinely given to patients after surgery.But maintain remission medications,as azathioprine,6-MP, ciclosporin,tripterygium glycosides, had a onset time.The therapeutic effect may appear 3 months~6months after taken medicine.There is a treatment blank period between surgery and onset time of maintain remission medications.Enteral nutrition has been used in the induction remission and maintain remission for CD.May be it can fill the treatment blank period.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects should have a definitive diagnosis of Crohn's disease, based on WHO criteria
- •Subjects having curative resection/ileocolonic anastomosis，pathologically diagnosed as Crohn's disease
- •Lesions located in ileum or ileocecal region
- •Males and females ≥ 18 years old, including women who are not pregnant or lactating at the time of enrollment.
- •Body weight between 40 and 100 kg, inclusive.
- •Subjects should have a CDAI score <150 at week 0
- •Able to swallow tablets
- •Are capable of providing written informed consent and obtained at the time of enrollment
- •Willing to adhere to the study visit schedule and other protocol requirements.
排除标准
- •Bacterial,viral or other microbial infection(including HIV)
- •any of the following medications taken within 12 weeks before surgery: cyclosporine, tacrolimus, sirolimus, mycophenolate mofetil, or other investigational drugs
- •any of ongoing therapy for Crohn's disease with: 5-ASA compounds, steroids, immune modifiers, systemic antibiotics, and tube feeding
- •Needing orally administered corticosteroids for the treatment of other diseases. Inhaled or dermatologic preparations are acceptable.
- •Previous or current use of infliximab.
- •current use of prescription doses or chronic/frequent use of NSAIDs
- •Treatment with narcotic pain medications. (Anti-diarrheal agents such as loperamide and diphenoxylate are permitted, providing that the dose is not increased during the study period.)
- •History of pancreatitis, except for subjects with a known but removed cause(such as gallstone pancreatitis)
- •WBC <3.0 x 109/L, hemoglobin <80 g/L, Platelets<50,000/mm3 at the time of enrollment (or within the previous 6 months, if known)
- •History of abnormal liver function tests, including AST or ALT >1.5 times upper limit of normal, alkaline phosphatase >2 times upper limit of normal, total bilirubin >2.5 mg/dL at screening (or within the previous 6 months, if known)
- •With short bowel syndrome (defined as requiring oral or parenteral supplemental or total nutrition to maintain stable body weight, or more than 100 cm of small bowel resected)
- •History of malignancy
- •Women who are pregnant or lactating at the time of enrollment, or who intend to be during the study period.
- •Participation in other clinical trial within the past 6 months
研究组 & 干预措施
enteral nutrition+azathioprine
Patients is fasting and receive enteral nutrition and azathioprine treatment.
干预措施: azathioprine+enteral nutrition (Drug)
azathioprine
Patients have regular diet and receive only azathioprine treatment.
干预措施: Azathioprine (Drug)
结局指标
主要结局
The change of patients'CDAI.
时间窗: at 0 week, the 4 weeks, the 8 weeks, the 12weeks
patients' endoscopic score(Rutgeerts score).
时间窗: at the 12weeks
次要结局
- The change of haematological inflammation marker(CRP,ESR)(at 0 week, the 4 weeks, the 8 weeks, the 12weeks)
- The change of patients'IBDQ.(at 2 week, the 6 weeks, the 12 weeks)
- The change of blood routine examination and blood biochemistry.(at 0 week,4 weeks,8 weeks,12 weeks)
研究者
Zhu Weiming
vice director of General surgery institute
Jinling Hospital, China