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

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Preoperative clinical remission rate [Срок оценки: From enrollment to the end of treatment at 6 weeks]

Вторичные конечные точки (5)

• Incidence of complications within 30 days post-surgery [Срок оценки: Within 30 days post-surgery]
• Changes in nutritional and inflammatory indicators before and after optimization [Срок оценки: From enrollment to the end of treatment at 6 weeks]
• Surgical anastomosis rate for phase I [Срок оценки: From enrollment to the end of surgery]
• Clinical recurrence rate at 12 weeks post-operation [Срок оценки: Within 12 weeks post-surgery]
• Histological status of surgical margins [Срок оценки: From enrollment to the end of surgery]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Sixth Affiliated Hospital, Sun Yat-sen University — Гуанчжоу

Идентификаторы

NCT: NCT06912815 · 2025ZSLYEC-069

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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