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

ConditionCrohn Disease (CD)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorXiang Gao

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • ustekinumab and semi enteral nutrition

    Biological/Vaccine

    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

    Other intervention

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

Treatment groups

184 Participants
are divided into 2 treatment groups
Group A: ustekinumab and semi enteral nutritionExperimental treatment 1 intervention
Group B: Exclusive enteral nutritionExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
From enrollment to the end of treatment at 6 weeks

Secondary outcomes

1

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.

Time frame
Within 30 days post-surgery
2

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.

Time frame
From enrollment to the end of treatment at 6 weeks
3

Surgical anastomosis rate for phase I

Compare the anastomosis rate after the first stage of surgery between two groups of optimized patients.

Time frame
From enrollment to the end of surgery
4

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.

Time frame
Within 12 weeks post-surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Xiang Gao

Lead sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Sponsor institution

Source ClinicalTrials.gov
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