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NCT Number: NCT06912815

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

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.

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Key information

Conditions

Crohn Disease (CD) Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510655, China

Location status: Recruiting

Location contact

Xiang Gao

CONTACT

[email protected]

+86-020-38663423

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Exclusive enteral nutrition

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Xiang Gao

CONTACT

[email protected]

+86-020-38663423

Sponsors and collaborators

Lead sponsor

Xiang Gao

Other

Registry information

Official study title

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

Acronym: USE-OPT CD

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 6, 2025
Registry last updated
Apr 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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