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

Sponsor
Xiang Gao
Study ID
NCT06912815
Status
Recruiting
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Conditions

  • Crohn Disease (CD)

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

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

Study Details

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.

Key Dates

Start date
Aug 1, 2024
Status verified
Apr 2025
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
184 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: ustekinumab and semi enteral nutrition
  • Experimental: Exclusive enteral nutrition

Primary Outcome Measure

Preoperative clinical remission rate [ Time Frame: From enrollment to the end of treatment at 6 weeks ]

Central Contacts

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