About this trial
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
Qualifiers
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;
Disqualifiers
Emergency surgery;
Had received exclusive enteral nutrition support within 3 months prior to surgery;
Unable to tolerate enteral nutrition;
Failed with UST;
Trial design
Treatments tested in this trial
- ustekinumab and semi enteral nutrition
- Exclusive enteral nutrition
Treatment groups
Sponsors and collaborators
Xiang Gao
Lead sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
Sponsor institution