An interventional study of ustekinumab and semi enteral nutrition and Exclusive enteral nutrition in Crohn Disease (CD), sponsored by Xiang Gao. Recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-04-06.
Sponsored by Xiang Gao · Not applicable, Interventional, and Treatment
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.
1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.
This study's planned enrollment of 184 is above the median of 66 across 1,188 interventional studies indexed under Crohn Disease.
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Exclusion Criteria:
Biological: ustekinumab and semi enteral nutrition
Other: Exclusive enteral nutrition
Preoperative treatment optimization involves a single intravenous induction with UST, followed by 6 weeks of oral/nasal feeding with semi-enteral nutrition.
Preoperative optimized treatment with 6 weeks of oral/nasal feeding of exclusive enteral nutrition alone.
Preoperative clinical remission rate
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.
Time frame: From enrollment to the end of treatment at 6 weeks
Incidence of complications within 30 days post-surgery
Postoperative day 3: Complete the QoR-15 questionnaire; Postoperative day 7: Re-examine blood routine, liver and kidney function, CRP, and intestinal color Doppler ultrasound; Postoperative week 4: Re-examine blood routine, liver and kidney function, CRP, intestinal color Doppler ultrasound, and complete the IBDQ questionnaire.
Time frame: Within 30 days post-surgery
Changes in nutritional and inflammatory indicators before and after optimization
Compare the baseline and the height, weight, and inflammatory indicators (including complete blood count, CRP, liver function, etc.) of two groups of patients after 6 weeks of treatment.
Time frame: From enrollment to the end of treatment at 6 weeks
Surgical anastomosis rate for phase I
Compare the anastomosis rate after the first stage of surgery between two groups of optimized patients.
Time frame: From enrollment to the end of surgery
Clinical recurrence rate at 12 weeks post-operation
Clinical relapse: Patients in clinical remission who, at any visit, have a Crohn's Disease Activity Index (CDAI) of 150 or higher.
Time frame: Within 12 weeks post-surgery
Histological status of surgical margins
Comparing the histological conditions of surgical margins in patients after optimization treatment between two groups, to verify whether UST + semi-enteral nutrition has a better therapeutic effect.
Time frame: From enrollment to the end of surgery
Plan to share: Undecided
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Xiang Gao