Ustekinumab With Semi-EN vs Exclusive EN for Preoperative Crohn's Disease Optimization.

NCT ID: NCT06912815

Last Updated: 2025-04-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 184 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-01
• Study Completion Date: 2026-09-30

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.

Conditions

Crohn Disease (CD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ustekinumab and semi enteral nutrition

Group Type: EXPERIMENTAL

ustekinumab and semi enteral nutrition

Intervention Type: BIOLOGICAL

Preoperative treatment optimization involves a single intravenous induction with UST, followed by 6 weeks of oral/nasal feeding with semi-enteral nutrition.

Exclusive enteral nutrition

Group Type: EXPERIMENTAL

Exclusive enteral nutrition

Intervention Type: OTHER

Preoperative optimized treatment with 6 weeks of oral/nasal feeding of exclusive enteral nutrition alone.

Interventions

ustekinumab and semi enteral nutrition

Preoperative treatment optimization involves a single intravenous induction with UST, followed by 6 weeks of oral/nasal feeding with semi-enteral nutrition.

Intervention Type: BIOLOGICAL

Exclusive enteral nutrition

Preoperative optimized treatment with 6 weeks of oral/nasal feeding of exclusive enteral nutrition alone.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xiang Gao

OTHER

Sponsor Role: lead

Responsible Party

Xiang Gao

Director of Gastroenterology

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiang Gao

Role: CONTACT

gxiang@mail.sysu.edu.cn

+86-020-38663423

Facility Contacts

Xiang Gao

Role: primary

gxiang@mail.sysu.edu.cn

+86-020-38663423

Other Identifiers

2025ZSLYEC-069

Identifier Type: -

Identifier Source: org_study_id