Status:
RECRUITING
Ustekinumab With Semi-EN vs Exclusive EN for Preoperative Crohn's Disease Optimization.
Lead Sponsor:
Xiang Gao
Conditions:
Crohn Disease (CD)
Eligibility:
All Genders
18-65 years
Phase:
NA
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). Cu...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
184 Patients enrolled
Trial Details
Trial ID
NCT06912815
Start Date
August 1 2024
End Date
September 1 2026
Last Update
April 6 2025
Active Locations (1)
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1
Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China, 510655