NCT06912815Recruiting
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
Source: ClinicalTrials.gov · Last updated 6 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 184 (estimated)
- First submitted
- 24 Mar 2025
- Start date
- 1 Aug 2024
- Primary completion date
- Sept 2026
- Lead sponsor
- Xiang Gao
- Diseases
- Crohn's disease
- NCT number
- NCT06912815
What you commit to
- Study type: Interventional
- Planned participants: 184
- From 1 Aug 2024 to the primary completion date, Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Emergency surgery;
- Had received exclusive enteral nutrition support within 3 months prior to surgery;
Other illness
- Pregnant or with co-existing intestinal outside organ dysfunction, tumor, rheumatological or immunological diseases, etc.
Other
- Unable to tolerate enteral nutrition;
- Failed with UST;
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sixth Affiliated Hospital, Sun Yat-sen University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.