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

April 2, 2025 updated by: Xiang Gao

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
184

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510655
        • Recruiting
        • Sixth Affiliated Hospital, Sun Yat-sen University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Preoperative clinical remission rate
Time Frame: From enrollment to the end of treatment at 6 weeks
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence of complications within 30 days post-surgery
Time Frame: 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
Time Frame: From enrollment to the end of treatment at 6 weeks
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
Time Frame: From enrollment to the end of surgery
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
Time Frame: Within 12 weeks post-surgery
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
Time Frame: From enrollment to the end of surgery
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Xiang Gao

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 24, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 6, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 6, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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