Ustekinumab With Semi-EN vs Exclusive EN for Preoperative Crohn's Disease Optimization. (USE-OPT CD)

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

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 Overview

• Status: Recruiting
• Conditions: Crohn Disease (CD)
• Intervention / Treatment: Biological: ustekinumab and semi enteral nutrition; Other: Exclusive enteral nutrition

• Study Type: Interventional
• Enrollment (Estimated): 184
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiang Gao; Phone Number: +86-020-38663423; Email: gxiang@mail.sysu.edu.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510655
      • Recruiting
      • Sixth Affiliated Hospital, Sun Yat-sen University
      • Contact: Xiang Gao; Phone Number: +86-020-38663423; Email: gxiang@mail.sysu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ustekinumab and semi enteral nutrition	Biological: 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.
Experimental: Exclusive enteral nutrition	Other: Exclusive enteral nutrition; Preoperative optimized treatment with 6 weeks of oral/nasal feeding of exclusive enteral nutrition alone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From enrollment to the end of treatment at 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	From enrollment to the end of surgery

Collaborators and Investigators

• Sponsor: Xiang Gao

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: March 24, 2025
• First Submitted That Met QC Criteria: April 2, 2025
• First Posted (Actual): April 6, 2025

Study Record Updates

• Last Update Posted (Actual): April 6, 2025
• Last Update Submitted That Met QC Criteria: April 2, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Crohn Disease; Dermatologic Agents; Ustekinumab
• Other Study ID Numbers: 2025ZSLYEC-069

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No