NCT06912815 Ustekinumab With Semi-EN vs Exclusive EN for Preoperative Crohn's Disease Optimization.
| NCT ID | NCT06912815 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Xiang Gao |
| Condition | Crohn Disease (CD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 184 participants |
| Start Date | 2024-08-01 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 184 participants in total. It began in 2024-08-01 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06912815 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Crohn Disease (CD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06912815 currently recruiting?
Yes, NCT06912815 is actively recruiting participants. Contact the research team at gxiang@mail.sysu.edu.cn for enrollment information.
Where is the NCT06912815 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT06912815 clinical trial?
NCT06912815 is sponsored by Xiang Gao. The trial plans to enroll 184 participants.