Clinical Trial

Guselkumab Vs Ustekinumab in Stricturing Crohn's Disease

Recruiting
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Summary
This study intends to select patients with confirmed moderate-to-severe Crohn's disease (CD) and obstructive symptoms of intestinal stenosis, who have clear evidence of lumen stenosis caused by the disease itself through radiography or endoscopy. After the informed consent of the patients, comprehensive drug therapy with Guselkumab or Ustekinumab as the mainstay was performed. The basic information and medical history of the patients were collected, and the treatment process of the patients was followed up and recorded, and the drug regimen was adjusted according to the physician's experience and judgment. At different follow-up time points, blood, feces, tissue and other specimens of patients were collected according to the situation, and gastrointestinal endoscopy, imaging examination, laboratory index examination, self-assessment of subjects' symptoms, and nutritional risk screening were performed on the patients. This study evaluated the CD disease activity, obstructive symptoms, and radiographic or endoscopic remission in patients at different follow-up time points, and comprehensively evaluated the efficacy of ustekinumab in relieving stenotic CD and its related factors.
Protocol Amendment History 1 change
notable Sponsor changed: Second Affiliated Hospital, School of Medicine, Zhejiang University -> Second Affiliated Hospital, Zhejiang University, School of Medicine 2026-08-09
Trial Details
NCT Number NCT07444060
Lead Sponsor Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators: People's Hospital of Chongqing
Conditions CD - Crohn's Disease, Stricture; Bowel, IBD - Inflammatory Bowel Disease
Enrollment 100 participants
Start Date 2026-03-01
Primary Completion 2028-12-31 (estimated)
Study Completion 2029-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-03-02