Combining Ustekinumab with Semi-Enteral Nutrition for Crohn's Disease Before Surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effectiveness of combining Ustekinumab, a biologic agent targeting Interleukin-12 and Interleukin-23, with semi-enteral nutrition in optimizing preoperative treatment for patients with Crohn's Disease. The approach aims to induce disease remission while improving the nutritional status of patients scheduled for surgical intervention. Eligible participants include adults aged 18-65 with a CDAI score greater than 150 who have not previously used Ustekinumab. The study will compare this combined treatment regimen against exclusive enteral nutrition to assess its potential benefits.

Why it matters

Who can join: the full rules

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.

Where it's running

• Sixth Affiliated Hospital, Sun Yat-sen University
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Xiang Gao
• Email: gxiang@mail.sysu.edu.cn
• Phone: +86-020-38663423

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Reducing ustekinumab dosing for Crohn's disease and ulcerative colitis

  This will try giving ustekinumab less often—changing from every 4 or 8 weeks to every 8 or 12 weeks—to see if people with Crohn's disease or ulcerative colitis in deep remission can stay well.

  Recruiting Phase 4 McGill University Health Centre/Research Institute of the McGill University Health Centre · Montreal, Quebec · NCT07303686

• Switching to guselkumab for adults with active IBD after ustekinumab

  We will try guselkumab (Tremfya) in adults with active IBD whose symptoms didn't improve enough on ustekinumab.

  Recruiting at 12 sites TIDHI Innovation Inc. · Calgary, Alberta and 13 other locations · NCT07245394

• Switching adults with Crohn's disease from Stelara (ustekinumab) to the biosimilar Uzpruvo

  This will see if adults with stable Crohn's disease who switch from Stelara® to the biosimilar Uzpruvo® stay on the biosimilar and remain well over 12 months.

  Recruiting at 10 sites EG Labo · Amiens and 10 other locations · NCT07077681

• Reduce ultra-processed foods to help kids with Crohn's stay in remission longer

  This study tests whether and how reducing ultra-processed foods with dietitian guidance helps children and teens with Crohn's disease stay in remission longer.

  Recruiting University Hospital, Motol · Prague and 1 other locations · NCT07884045

• Endoscopic stricturotomy vs balloon dilation for small bowel Crohn’s stricture

  This trial tests whether endoscopic stricturotomy can be safely and effectively used to treat small bowel fibrotic strictures in Crohn’s disease, compared with endoscopic balloon dilation.

  Recruiting Sixth Affiliated Hospital, Sun Yat-sen University · Guangzhou, Guangdong · NCT07833332

• Prediction of postoperative recurrence in Crohn's disease after surgery

  A multicenter study will test a multimodal model to predict which Crohn's patients are likely to have disease recur after intestinal resection.

  Recruiting Sixth Affiliated Hospital, Sun Yat-sen University · Guangzhou, Guangdong · NCT07824791

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.