Comparative Analysis of Curative Effect Ustekinumab Combined With Semi Enteral Nutrition and Exclusive Enteral Nutrition in Preoperative Optimization of Crohn's Disease: A Multicenter, Prospective, Randomized, Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 184
- 试验地点
- 1
- 主要终点
- Preoperative clinical remission rate
研究概览
简要总结
Ustekinumab (UST) is a novel biologic agent that targets and binds to Interleukin-12 (IL-12) and Interleukin-23 (IL-23), and is approved for inducing and maintaining remission in Crohn Disease(CD). Currently, it is believed that the use of UST for the preoperative treatment of CD patients is generally safe and does not increase surgical complications, and it can be used for preoperative treatment of CD. However, there is still a lack of literature reporting the role of UST in preoperative optimization for CD. Semi-enteral nutrition refers to the provision of more than 50% of the energy required by the human body through enteral nutrition preparations. Semi-enteral nutrition can improve the nutritional status of patients with CD, but it does not induce remission of active disease. The treatment method of UST combined with semi-enteral nutrition can not only induce disease remission, but also improve the nutritional status of patients. Therefore, can the combined treatment regimen replace Exclusive Enteral nutrition (EEN) as a new therapy for preoperative optimization of CD? At present, there is a lack of relevant research, so this study intends to conduct a multi-center, prospective, randomized controlled trial to compare the efficacy differences between UST+semi-enteral nutrition and EEN in preoperative optimization for CD, and to clarify the preoperative optimization effect of UST combined with semi-enteral nutrition therapy.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CD patients with surgical indications, who are scheduled for partial intestinal resection and anastomosis;
- •CD patients diagnosed prior to surgery;
- •Patients aged 18-65;
- •CDAI score of >150;
- •For patients with peritoneal abscess, they must receive adequate antibiotics and drainage prior to enrollment, and be confirmed to be free of infection before enrolling in the study;
- •The patients agree to participate in the study and sign an informed consent form;
- •Patients who have not used ustekinumab prior to surgery;
- •Patients who have tried other treatments and found them ineffective, and plan to stop using them and schedule surgery.
排除标准
- •Emergency surgery;
- •Had received exclusive enteral nutrition support within 3 months prior to surgery;
- •Unable to tolerate enteral nutrition;
- •Failed with UST;
- •Pregnant or with co-existing intestinal outside organ dysfunction, tumor, rheumatological or immunological diseases, etc.
研究组 & 干预措施
ustekinumab and semi enteral nutrition
干预措施: ustekinumab and semi enteral nutrition (Biological)
Exclusive enteral nutrition
干预措施: Exclusive enteral nutrition (Other)
结局指标
主要结局
Preoperative clinical remission rate
时间窗: From enrollment to the end of treatment at 6 weeks
Patients enrolled should collect basic information such as height, weight, disease activity at baseline, and complete examinations including complete blood count, blood biochemistry (electrolytes, liver and kidney function), C-reactive protein, CTE/MRE, intestinal color Doppler ultrasound, nutritional risk NRS2002 score, colonoscopy, as well as iron, calcium, folic acid, and other trace elements. These indicators should be rechecked after 6 weeks post-enrollment.Compare the clinical remission rates of two groups of patients after treatment.
次要结局
- Changes in nutritional and inflammatory indicators before and after optimization(From enrollment to the end of treatment at 6 weeks)
- Surgical anastomosis rate for phase I(From enrollment to the end of surgery)
- Clinical recurrence rate at 12 weeks post-operation(Within 12 weeks post-surgery)
- Histological status of surgical margins(From enrollment to the end of surgery)
- Incidence of complications within 30 days post-surgery(Within 30 days post-surgery)
研究者
Xiang Gao
Director of Gastroenterology
Sixth Affiliated Hospital, Sun Yat-sen University