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Crohn'sRecruiting

Guselkumab Vs Ustekinumab in Stricturing Crohn's Disease

Observational · No treatment assigned · 1 site · Second Affiliated Hospital, Zhejiang University, School of Medicine

Official record & contacts on ClinicalTrials.gov ↗

In plain English

What this trial is testing

Condition(s) listed: CD - Crohn's Disease, Stricture; Bowel and IBD - Inflammatory Bowel Disease. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.

Who can join

Some of the main requirements, copied from the record:

Plus 2 more requirement(s). There are also 13 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.

What's involved

Main thing being measured

In the researchers’ words

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.

This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.

Questions to ask your doctor and the trial team

Official details

StatusRecruiting
PhaseObservational
Study typeObservational
ConditionsCD - Crohn's Disease; Stricture; Bowel; IBD - Inflammatory Bowel Disease
Lead sponsorSecond Affiliated Hospital, Zhejiang University, School of Medicine
CollaboratorsPeople's Hospital of Chongqing
Enrollment100 (estimated)
Start date2026-03-01
Primary completion (est.)2028-12-31
First posted2026-03-02
Last updated2026-03-02
Official titleEfficacy of Guselkumab Versus Ustekinumab in Stricturing Crohn's Disease: A Multicenter, Prospective, Observational Cohort Study
ClinicalTrials.gov IDNCT07444060

Interventions

Full eligibility criteria (from the record)
Inclusion Criteria:

* Confirmed patients with moderate-to-severe Crohn's disease (CD), aged 18 to 80 years, receiving treatment with Guselkumab or Ustekinumab.
* Presence of obstructive symptoms consistent with chronic or subacute intestinal obstruction within the past 8 weeks, with confirmed postprandial abdominal pain attributable to strictures, with the exclusion of: ① mild to moderate pain (postprandial abdominal pain or abdominal pain exacerbated by diet, ameliorated with abdominal bowel sounds) without nausea, vomiting or abdominal colic; ② dietary restrictions unrelated to abdominal pain.
* Evidence of definite luminal strictures caused by the disease itself confirmed by radiographic imaging or endoscopic examination, i.e., meeting any of the following criteria:

  1. Enteric computed tomography (CT): Presence of intestinal strictures on enteric CT, with two of the three following findings at the stricture site compared with the adjacent proximal bowel: ① a >50% reduction in luminal diameter; ② a >25% increase in bowel wall thickness; ③ pre-stenotic dilation >2.5 cm.
  2. Endoscopic examination: Intestinal strictures that are impassable to the endoscope.

Exclusion Criteria:

* Patients with severe disease requiring emergency surgery or endoscopic therapeutic intervention, or those judged by the attending clinician to need a switch of medication or elective surgery within 2 months, such as those with acute severe intestinal obstruction, perforation, intra-abdominal abscess, intra-abdominal adhesion, and other conditions leading to obstruction, hemorrhage, infection, etc.
* Intestinal obstruction, intra-abdominal abscess, isolated intestinal stricture and other lesions secondary to surgery.
* Patients who have received definitive therapeutic interventions for strictures within the past 6 months, such as endoscopic balloon dilation, stricture incision, intestinal stricture plasty, surgical/manual anal dilatation, etc.
* Severe patients who remain unable to take oral intake despite enteral nutrition (EN) administration for more than 2 months.
* Patients who have used Guselkumab (GUS), Ustekinumab (UST) or other IL-23 antagonists within the past 12 months; or those with contraindications to GUS/UST, or intolerance to the study medications due to other causes (e.g., allergy to IL-23 antagonists).
* Patients with contraindications to small intestinal computed tomography (CT), such as contrast media allergy.
* Patients with relative contraindications to biological agents, such as active tuberculosis with a positive chest X-ray for pulmonary tuberculosis or a strongly positive tuberculin skin test; a history of myocardial infarction, heart failure or demyelinating neurological diseases within the past 5 years.
* Patients currently suffering from solid tumors, with a past history of lymphoma or melanoma, or undergoing chemotherapy or radiotherapy.
* Patients complicated with intestinal dysplasia (e.g., diagnosed with short bowel syndrome), colostomy or colorectal neoplasms.
* Patients complicated with active massive gastrointestinal hemorrhage, severe hepatic and renal dysfunction, active bacterial or viral infection, shock, as well as intractable vomiting and severe malabsorption syndrome.
* Pregnant or lactating patients.
* Patients with severe hemodynamic and vital sign instability, or those with rapidly progressive or end-stage diseases.
* Patients with psychiatric disorders, or those with insufficient educational level to fully understand the study content or unable to cooperate with the completion of the study.

Locations (1)

SiteCityCountrySite status
Second Affiliated Hospital, School of Medicine, Zhejiang UniversityHangzhou, ZhejiangChinaRecruiting

For contacts at each site, use the official record.

Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.