Clinical trial NCT06912815: Ustekinumab With Semi-EN vs Exclusive EN for Preoperative Crohn's Disease Optimization.
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Crohn Disease (CD)
Lead sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2025-04-06
Enrollment: 184
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Preoperative clinical remission rate
timeFrame: From enrollment to the end of treatment at 6 weeks
Secondary outcomes:
measure: Incidence of complications within 30 days post-surgery
timeFrame: Within 30 days post-surgery
measure: Changes in nutritional and inflammatory indicators before and after optimization
timeFrame: From enrollment to the end of treatment at 6 weeks
measure: Surgical anastomosis rate for phase I
timeFrame: From enrollment to the end of surgery
measure: Clinical recurrence rate at 12 weeks post-operation
timeFrame: Within 12 weeks post-surgery
measure: Histological status of surgical margins
timeFrame: From enrollment to the end of surgery
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sixth Affiliated Hospital, Sun Yat-sen University
state: Guangdong
Study officials:
References: