RecruitingNot ApplicableNCT06912815

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

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


Sponsor

Xiang Gao

Enrollment

184 participants

Start Date

Aug 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two approaches to prepare people with Crohn's disease for bowel surgery: the biologic drug ustekinumab combined with tube feeding (semi-exclusive enteral nutrition) versus tube feeding alone, to see which reduces complications and improves recovery. **You may be eligible if...** - You have been diagnosed with Crohn's disease - You are scheduled for partial bowel removal surgery - You are between 18 and 65 years old - Your Crohn's disease is currently active (CDAI score above 150) - You have not previously used ustekinumab - You have tried other treatments that have not worked **You may NOT be eligible if...** - You need emergency surgery - You have had exclusive tube feeding within the past 3 months before surgery - You cannot tolerate tube feeding - You are pregnant or have cancer, rheumatological, or immune diseases alongside your Crohn's Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALustekinumab 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.

OTHERExclusive enteral nutrition

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


Locations(1)

Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

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NCT06912815


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