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

NCT06912815 | Recruiting DMC

• 1 other identifier: 2025ZSLYEC-069
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 1

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)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Incidence of complications within 30 days post-surgery

  Within 30 days post-surgery

• Changes in nutritional and inflammatory indicators before and after optimization

  From enrollment to the end of treatment at 6 weeks

• Surgical anastomosis rate for phase I

  From enrollment to the end of surgery

• Clinical recurrence rate at 12 weeks post-operation

  Within 12 weeks post-surgery

• Histological status of surgical margins

  From enrollment to the end of surgery

Study Arms (2)

ustekinumab and semi enteral nutrition

EXPERIMENTAL

Biological: ustekinumab and semi enteral nutrition

Exclusive enteral nutrition

EXPERIMENTAL

Other: Exclusive enteral nutrition

Interventions

ustekinumab and semi enteral nutrition BIOLOGICAL

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

ustekinumab and semi enteral nutrition

Exclusive enteral nutrition OTHER

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

Exclusive enteral nutrition

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xiang Gao: lead

Study Sites (1)

Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510655, China

RECRUITING

MeSH Terms

Conditions

Crohn Disease

Interventions

Ustekinumab

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Xiang Gao

CONTACT

+86-020-38663423; gxiang@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Gastroenterology

Study Record Dates

• First Submitted: March 24, 2025
• First Posted: April 6, 2025
• Study Start: August 1, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: April 6, 2025

Record last verified: 2025-04

Locations

CN (1)