Actively Recruiting
Guselkumab Vs Ustekinumab in Stricturing Crohn's Disease
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2026-03-02
100
Participants Needed
1
Research Sites
200 weeks
Total Duration
On this page
Sponsors
S
Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead Sponsor
P
People's Hospital of Chongqing
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Guselkumab Vs Ustekinumab in Stricturing Crohn's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed moderate-to-severe Crohn's disease in patients aged 18 to 80 years treated with Guselkumab or Ustekinumab
- Obstructive symptoms consistent with chronic or subacute intestinal obstruction within the past 8 weeks
- Postprandial abdominal pain caused by strictures, excluding mild to moderate pain without nausea, vomiting, or colic, and excluding dietary restrictions unrelated to pain
- Definite luminal strictures caused by Crohn's disease confirmed by radiographic imaging or endoscopy:
- Intestinal strictures on enteric CT with at least two of the following: >50% reduction in luminal diameter, >25% increase in bowel wall thickness, or pre-stenotic dilation >2.5 cm
- Intestinal strictures impassable to endoscope during endoscopic examination
You will not qualify if you...
- Severe disease requiring emergency surgery or intervention, or planned medication change or elective surgery within 2 months
- Acute severe intestinal obstruction, perforation, intra-abdominal abscess, adhesion, or other conditions causing obstruction, bleeding, or infection
- Intestinal obstruction, abscess, isolated stricture, or other lesions secondary to surgery
- Definitive stricture treatments (e.g., balloon dilation, stricture incision, strictureplasty) within past 6 months
- Inability to take oral intake despite enteral nutrition for over 2 months
- Use of Guselkumab, Ustekinumab, or other IL-23 antagonists within past 12 months, or contraindications or intolerance to study drugs
- Contraindications to small intestinal CT such as contrast allergy
- Relative contraindications to biologics including active tuberculosis or recent myocardial infarction, heart failure, or demyelinating diseases
- Current solid tumors, past lymphoma or melanoma, or ongoing chemotherapy/radiotherapy
- Intestinal dysplasia, colostomy, or colorectal neoplasms
- Active massive gastrointestinal bleeding, severe liver/kidney dysfunction, active infections, shock, intractable vomiting, or severe malabsorption
- Pregnancy or lactation
- Severe hemodynamic instability or rapidly progressive/end-stage diseases
- Psychiatric disorders or insufficient education to understand or complete the study
AI-Screening
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Trial Site Locations
Total: 1 location
1
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
Research Team
Y
Yan Chen
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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