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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 184
- Locations
- 1
- Primary Endpoint
- Preoperative clinical remission rate
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
ustekinumab and semi enteral nutrition
Intervention: ustekinumab and semi enteral nutrition (Biological)
Exclusive enteral nutrition
Intervention: Exclusive enteral nutrition (Other)
Outcomes
Primary Outcomes
Preoperative clinical remission rate
Time Frame: 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.
Secondary Outcomes
- Histological status of surgical margins(From enrollment to the end of surgery)
- 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)
- Incidence of complications within 30 days post-surgery(Within 30 days post-surgery)
Investigators
Xiang Gao
Director of Gastroenterology
Sixth Affiliated Hospital, Sun Yat-sen University